POLAROID INSTANT ENDOCAMERA— 510(k) K812542

Name: FDA 510(k) clearance K812542
Creator: U.S. Food and Drug Administration
Published: 1981-10-19

Substantially Equivalent

Polaroid Corp.

FDA 510(k) clearance K812542 for POLAROID INSTANT ENDOCAMERA, Substantially Equivalent on 1981-10-19. Applicant: Polaroid Corp.. Device class: 1.

Clearance details

Applicant: Polaroid Corp.
Product code: Code FEM
Device class: Class 1
Regulation: 21 CFR 876.1500
Advisory panel: Gastroenterology, Urology
Date received: 1981-09-04
Decision date: 1981-10-19
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, 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.