Product code DPS— Cardiovascular
DIGITAL ELECTROCARDIOGRAPH
- Advisory panel
- Cardiovascular
- Total cleared
- 576
Adverse events under product code DPS
product code DPS- Death
- 7
- Total
- 7
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Recent clearances under product code DPS
1–100 of 576- K252463 — SE-1202 Series Electrocardiograph (Model: SE-1202, SE-1202E)
- K251670 — MAC 7 Resting ECG Analysis System
- K252361 — AccurECG Analysis System (v2.0)
- K252474 — Withings BeamO (SCT02)
- K250569 — Cardiologs Holter Platform
- K243252 — ZBPro Diagnostic
- K243305 — Masimo W1
- K241217 — CloudHRV System (100-01-001)
- K241556 — Cardiac Workstation (5000); Cardiac Workstation (7000)
- K240229 — Masimo W1
- K232161 — DeepRhythm Platform
- K233266 — MEDIBLU ECG SYSTEM
- K232035 — Impala
- K232816 — Electrocardiograph, model: ECG301
- K232445 — CSF-4 (CSF-4)
- K232823 — MCG-S (AM1000)
- K231160 — Cardio Q50, Cardio Q70
- K230834 — CARDIPIA ECG / Model: CARDIPIA400H, CARDIPIA800H
- K232512 — Masimo W1
- K232974 — EKGenius Smart System
- K231150 — Cardio P1
- K230812 — Withings Scan Monitor 2.0
- K222902 — Electrocardiograph: SE-1200 Pro and SE-1201 Pro
- K223670 — MESI mTablet ECG Diagnostic System, MESI mTablet ECG
- K223013 — AccurECG Analysis System
- K221260 — CSF-3
- K221141 — PageWriter TC35 Cardiograph
- K220535 — Cardio10
- K221321 — MAC 5 A4/ MAC 5 A5/ MAC 5 Lite Resting ECG Analysis System
- K212163 — Coala Heart Monitor
- K212278 — Electrocardiograph
- K220362 — LE-12CH
- K212112 — Cardiologs Holter Platform
- K201456 — Scan Monitor
- K210140 — electrocardiograph: SE-1202
- K210560 — Page Writer TC20 Cardiograph, Page Writer TC30 Cardiograph, Page Writer TC50 Cardiograph, Page Writer TC70 Cardiograph
- K203786 — MAC 7 - Resting ECG Analysis System
- K200884 — B-Secur HeartKey Software Library
- K191738 — PageWriter TC20 Cardiograph, PageWriter TC30 Cardiograph, PageWriter TC50 Cardiograph, PageWriter TC70 Cardiograph
- K193415 — physIQ Heart Rhythm and Respiration Module
- K200036 — AI-ECG Tracker
- K183425 — CARDIOVIT AT-102 G2
- K191692 — KardioScreen
- K183322 — physIQ Heart Rhythm and Respiratory Module
- K182571 — CardioFlux with Faraday Analytical Cloud
- K182093 — ZOLL ECG Analysis Software
- K183369 — COR12 ECG
- K182790 — Cardio-TriTest v6.5
- K181998 — CardioBand ECG Event Recorder
- K173830 — MAC VU360 Resting ECG Analysis System
- K173952 — Universal SmartECG
- K180234 — physiQ Heart Rhythm Module
- K172778 — CheckMyHeart Plus
- K172068 — Kenz Cardico1211
- K173226 — CardiMax Electrocardiograph
- K180242 — HeRO Symphony, HeRO ES, HeRO solo/duet
- K162665 — MiCor A100 Wearable ECG Recorder
- K171942 — Electrocardiograph
- K171360 — CONTEC Electrocardiograph
- K171517 — Digital Electrocardiograph
- K163607 — ECG Acquisition Systems
- K170154 — Creavo Vitalscan Magnetocardiograph
- K171943 — Electrocardiograph
- K170182 — CARDIOVIT FT-1
- K170568 — CardioLogs ECG Analysis Platform
- K170995 — Electrocardiograph
- K170954 — Portable ECG Monitor
- K160667 — Anybattery C2 Rechargeable Battery
- K160876 — PC ECG
- K160746 — CARDIOLINE touchECG
- K160840 — ECG100+, ECG200+
- K152135 — Quantitative Electrocardiographic Detector (QED 2000)
- K161302 — PC ECG
- K152863 — Portable ECG Monitor
- K152043 — Diagnostic Station DS20
- K151135 — MODEL 621/624 BIOMAGNETOMETER
- K142969 — ANI Monitor
- K160092 — Digital Electrocardiograph
- K152427 — PC ECG
- K152944 — Xscribe Stress Exercise Testing Systems, Q-Stress Stress Exercise Testing Systems
- K152384 — Digital Electrocardiograph
- K150564 — Spaulding Electrocardiograph 2100iQ
- K143432 — Cardio-TriTest
- K143436 — InvisionECG System
- K142551 — QANS (Quantitative Autonomic Nervous System) Monitoring System
- K142693 — ZywieAI Software Library
- K141946 — DIGITAL ELECTROCARDIOGRAPH
- K133985 — DIGITAL ELECTROCARDIOGRAPH
- K142288 — MAC 800 Resting ECG Analysis System
- K140020 — HYPERQ ACS-100 SYSTEM
- K142105 — ELI 380 ELECTROCARDIOGRAPH
- K141582 — CP150 ELECTROCARDIOGRAPH WITH SPIROMETRY OPTION
- K131858 — DIGITAL ELECTROCARDIOGRAPH
- K131900 — CONTEC ELECTROCARDIOGRAPH
- K131503 — SE-601 SERIES ELECTROCARDIOGRAPH
- K122632 — GUAVA II
- K130921 — ALIVECOR HEART MONITOR OTC
- K132758 — DIGITAL ELECTROCARDIOGRAPH
- K133622 — MAC 2000 ECG ANALYSIS SYSTEM
- K131819 — PC ECG
Data sourced from openFDA. This site is unofficial and independent of the FDA.