CARDIO-CARD ECG MANAGEMENT SYSTEM— 510(k) K920020

Name: FDA 510(k) clearance K920020
Creator: U.S. Food and Drug Administration
Published: 1992-07-09

Substantially Equivalent

Nasiff Assoc., Inc.

FDA 510(k) clearance K920020 for CARDIO-CARD ECG MANAGEMENT SYSTEM, Substantially Equivalent on 1992-07-09. Applicant: Nasiff Assoc., Inc.. Device class: 2.

Clearance details

Applicant: Nasiff Assoc., Inc.
Product code: Code DPS
Device class: Class 2
Regulation: 21 CFR 870.2340
Advisory panel: Cardiovascular
Date received: 1992-01-02
Decision date: 1992-07-09
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Brewerton, NY, US

Download summary PDF View on FDA.gov ↗

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K252474 — Withings BeamO (SCT02)2025-11-10
K250569 — Cardiologs Holter Platform2025-08-06

More clearances from Nasiff Assoc., Inc.

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K993616 — CARDIO-CARD INTERPRETATION SYSTEM I2000-04-10
K972795 — CARDIO-CARD MANAGEMENT SYSTEM II1998-02-20
K960544 — CARDIO-CARD HOLTER ECG MANAGEMENT SYSTEM1996-08-07
K903722 — MICROMED QRS CARD1990-12-05

Adverse events under product code DPS

product code DPS

Death: 7
Total: 7

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.