REUSABLE, ADJUSTABLE, MAGNETIC PEEP VALVE BE 142— 510(k) K963347

Substantially Equivalent

Instrumentation Industries, Inc.

FDA 510(k) clearance K963347 for REUSABLE, ADJUSTABLE, MAGNETIC PEEP VALVE BE 142, Substantially Equivalent on 1997-03-19. Applicant: Instrumentation Industries, Inc..

Clearance details

Applicant: Instrumentation Industries, Inc.
Product code: Code BYE
Advisory panel: Anesthesiology
Date received: 1996-08-26
Decision date: 1997-03-19
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Bethel Park, PA, US

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Adverse events under product code BYE

product code BYE

Death: 5
Total: 5

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.