SUPER AIR 9000 ALTERNATING AIR FLOATATION MATTRESS SYSTEM— 510(k) K970081

Substantially Equivalent

Cathay Consolidated, Inc.

FDA 510(k) clearance K970081 for SUPER AIR 9000 ALTERNATING AIR FLOATATION MATTRESS SYSTEM, Substantially Equivalent on 1997-11-07. Applicant: Cathay Consolidated, Inc..

Clearance details

Applicant: Cathay Consolidated, Inc.
Product code: Code FNM
Advisory panel: General Hospital
Date received: 1997-01-09
Decision date: 1997-11-07
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Taipei, TW

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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.