MICROAIR TURN-Q— 510(k) K926456

Substantially Equivalent

Gsi Development Co.

FDA 510(k) clearance K926456 for MICROAIR TURN-Q, Substantially Equivalent on 1993-03-24. Applicant: Gsi Development Co.. Device class: 2.

Clearance details

Applicant
Gsi Development Co.
Product code
Code IOQ
Device class
Class 2
Regulation
21 CFR 890.5170
Advisory panel
Physical Medicine
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Carmel, NY, US
Download summary PDFView on FDA.gov ↗

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Adverse events under product code IOQ

product code IOQ
Malfunction
676
Other
5
Total
681

Source: openFDA MAUDE database, through . 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.