PM9000 VAC TRAP— 510(k) K941818

Substantially Equivalent

Precision Medical, Inc.

FDA 510(k) clearance K941818 for PM9000 VAC TRAP, Substantially Equivalent on 1994-12-12. Applicant: Precision Medical, Inc..

Clearance details

Applicant: Precision Medical, Inc.
Product code: Code KDQ
Advisory panel: General Hospital
Date received: 1994-04-13
Decision date: 1994-12-12
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Northampton, PA, US

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Adverse events under product code KDQ

product code KDQ

Death: 8
Malfunction: 637
Total: 645

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.