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

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..

Clearance details

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

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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.