ENGUARD REMOTE PATIENT MONITOR— 510(k) K020632

Name: FDA 510(k) clearance K020632
Creator: U.S. Food and Drug Administration
Published: 2002-03-15

Substantially Equivalent

Mennen Medical , Ltd.

FDA 510(k) clearance K020632 for ENGUARD REMOTE PATIENT MONITOR, Substantially Equivalent on 2002-03-15. Applicant: Mennen Medical , Ltd.. Device class: 2.

Clearance details

Applicant: Mennen Medical , Ltd.
Product code: Code QYX
Device class: Class 2
Regulation: 21 CFR 870.1025
Advisory panel: Cardiovascular
Date received: 2002-02-27
Decision date: 2002-03-15
Decision: Substantially Equivalent
Clearance type: Special
Location: Rehovot, IL

Download summary PDF View on FDA.gov ↗

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Adverse events under product code QYX

product code QYX

Death: 13
Malfunction: 526
Total: 539

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.