PRESTIGE MEDICAL SERIES 2100 CLINICAL AUTOCLAVE— 510(k) K962903

Substantially Equivalent

Prestige Medical Corp.

FDA 510(k) clearance K962903 for PRESTIGE MEDICAL SERIES 2100 CLINICAL AUTOCLAVE, Substantially Equivalent on 1998-03-03. Applicant: Prestige Medical Corp..

Clearance details

Applicant: Prestige Medical Corp.
Product code: Code FLE
Advisory panel: General Hospital
Date received: 1996-07-25
Decision date: 1998-03-03
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Washington, DC, US

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Adverse events under product code FLE

product code FLE

Malfunction: 444
Total: 444

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.