POLAROID LAND CAMERA FOR ENDOSCOPY— 510(k) K792512

Name: FDA 510(k) clearance K792512
Creator: U.S. Food and Drug Administration
Published: 1979-12-20

Substantially Equivalent

Polaroid Corp.

FDA 510(k) clearance K792512 for POLAROID LAND CAMERA FOR ENDOSCOPY, Substantially Equivalent on 1979-12-20. 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: 1979-12-05
Decision date: 1979-12-20
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

Download summary PDF View on FDA.gov ↗

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K940152 — CAMERA COVER WITH TEAR TIP1994-10-28
K812201 — PHOTOGRAPHIC EQUIPMENT1981-10-19
K812542 — POLAROID INSTANT ENDOCAMERA1981-10-19

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K812088 — POLAROID RADIOGRAPHIC FILM PROCESSOR1981-08-31
K812089 — POLAROID RADIOGRAPHIC FILM CASSETTE1981-08-31
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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.