MICROAIR PUP— 510(k) K925694

Name: FDA 510(k) clearance K925694
Creator: U.S. Food and Drug Administration
Published: 1993-03-24

Substantially Equivalent

Gsi Medical Systems

FDA 510(k) clearance K925694 for MICROAIR PUP, Substantially Equivalent on 1993-03-24. Applicant: Gsi Medical Systems. Device class: 2.

Clearance details

Applicant: Gsi Medical Systems
Product code: Code IOQ
Device class: Class 2
Regulation: 21 CFR 890.5170
Advisory panel: Physical Medicine
Date received: 1992-11-12
Decision date: 1993-03-24
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Carmel, NY, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code IOQ

view all

K143414 — Hill-Rom Wireless Connectivity Module2015-03-10
K122473 — TOTALCARE SPOT TOTALCARE BARIATRIC TOTALCARE DUO TOATALCARE BED SYSTEM TOTALCARE DUO22013-06-03
K973624 — NURSE'S AID PATIENT ROTATION SYSTEM1998-01-21
K970363 — HYDROTEC LOW AIR LOSS THERAPY BED1997-11-17
K970364 — AIRTEC2 LOW AIR LOSS THERAPY BED1997-11-17

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.