510(k) K883192— SMI 3000 AIRBED

Substantially Equivalent

Smi Patientcare, Inc.

Clearance details

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

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.