MICROAIR PUP— 510(k) K925694

Substantially Equivalent

Gsi Medical Systems

FDA 510(k) clearance K925694 for MICROAIR PUP, Substantially Equivalent on 1993-03-24. Applicant: Gsi Medical Systems.

Clearance details

Applicant: Gsi Medical Systems
Product code: Code IOQ
Advisory panel: Physical Medicine
Date received: 1992-11-12
Decision date: 1993-03-24
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Carmel, NY, US

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Adverse events under product code IOQ

product code IOQ

Malfunction: 676
Other: 5
Total: 681

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.