S-57 VIDEO IMAGING SYSTEM— 510(k) K962024

Substantially Equivalent

Del Medical Systems Corp.

FDA 510(k) clearance K962024 for S-57 VIDEO IMAGING SYSTEM, Substantially Equivalent on 1996-07-09. Applicant: Del Medical Systems Corp..

Clearance details

Applicant: Del Medical Systems Corp.
Product code: Code FET
Advisory panel: Gastroenterology, Urology
Date received: 1996-05-23
Decision date: 1996-07-09
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Valhalla, NY, US

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Adverse events under product code FET

product code FET

Injury: 313
Malfunction: 54,276
Total: 54,589

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.