ALTERNATING PRESSURE AIR FLOTATION MATTRESS— 510(k) K972153

Substantially Equivalent

Decubiti Concepts, Inc.

FDA 510(k) clearance K972153 for ALTERNATING PRESSURE AIR FLOTATION MATTRESS, Substantially Equivalent on 1997-07-31. Applicant: Decubiti Concepts, Inc..

Clearance details

Applicant: Decubiti Concepts, Inc.
Product code: Code FNM
Advisory panel: General Hospital
Date received: 1997-06-09
Decision date: 1997-07-31
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mt Pleasant, SC, 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.