SMI 3000 AIRBED— 510(k) K883192

Name: FDA 510(k) clearance K883192
Creator: U.S. Food and Drug Administration
Published: 1988-10-26

Substantially Equivalent

Smi Patientcare, Inc.

FDA 510(k) clearance K883192 for SMI 3000 AIRBED, Substantially Equivalent on 1988-10-26. Applicant: Smi Patientcare, Inc.. Device class: 2.

Clearance details

Applicant: Smi Patientcare, Inc.
Product code: Code IOQ
Device class: Class 2
Regulation: 21 CFR 890.5170
Advisory panel: Physical Medicine
Date received: 1988-07-28
Decision date: 1988-10-26
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Lansing, MI, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code IOQ

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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.