MICROAIR BY INVACARE MODEL APM ALTERNATING PRESSURE AIR FLOTATION MATRESS— 510(k) K960411

Name: FDA 510(k) clearance K960411
Creator: U.S. Food and Drug Administration
Published: 1996-03-18

Substantially Equivalent

Invacare Corp.

FDA 510(k) clearance K960411 for MICROAIR BY INVACARE MODEL APM ALTERNATING PRESSURE AIR FLOTATION MATRESS, Substantially Equivalent on 1996-03-18. Applicant: Invacare Corp.. Device class: 2.

Clearance details

Applicant: Invacare Corp.
Product code: Code FNM
Device class: Class 2
Regulation: 21 CFR 880.5550
Advisory panel: General Hospital
Date received: 1996-01-29
Decision date: 1996-03-18
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Elyria, OH, US

Download summary PDF View on FDA.gov ↗

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Adverse events under product code FNM

product code FNM

Death: 22
Injury: 349
Other: 4
Total: 375

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.