CAMERA COVER WITH TEAR TIP— 510(k) K940152

Name: FDA 510(k) clearance K940152
Creator: U.S. Food and Drug Administration
Published: 1994-10-28

Substantially Equivalent

Hydro-Med Products, Inc.

FDA 510(k) clearance K940152 for CAMERA COVER WITH TEAR TIP, Substantially Equivalent on 1994-10-28. Applicant: Hydro-Med Products, Inc.. Device class: 1.

Clearance details

Applicant: Hydro-Med Products, Inc.
Product code: Code FEM
Device class: Class 1
Regulation: 21 CFR 876.1500
Advisory panel: Gastroenterology, Urology
Date received: 1994-01-03
Decision date: 1994-10-28
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Dallas, TX, US

Download summary PDF View on FDA.gov ↗

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Adverse events under product code FEM

product code FEM

Malfunction: 568
Total: 568

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.