DeviceClearance

PATIENT CABLES FOR MONITORING, I.E., ECG, EKG, SPO2, AND BP INTERFACE CABLES AND LEADWIRES— 510(k) K992524

Substantially Equivalent

Advantage Medical Electronics, Inc.

FDA 510(k) clearance K992524 for PATIENT CABLES FOR MONITORING, I.E., ECG, EKG, SPO2, AND BP INTERFACE CABLES AND LEADWIRES, Substantially Equivalent on 2000-03-01. Applicant: Advantage Medical Electronics, Inc.. Device class: 2.

Clearance details

Applicant
Advantage Medical Electronics, Inc.
Product code
Product code DSA
Device class
Class 2
Regulation
21 CFR 870.2900
Advisory panel
Cardiovascular
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Coral Springs, FL, US
Download summary PDFView on FDA.gov ↗

Recent devices under product code DSA

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Adverse events under product code DSA

product code DSA
Death
2
Total
2

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 →

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