LAKE STAGEZERO(TM) AIR FLOTATION BED— 510(k) K943162

Substantially Equivalent

Lake Medical Products, Inc.

FDA 510(k) clearance K943162 for LAKE STAGEZERO(TM) AIR FLOTATION BED, Substantially Equivalent on 1995-02-27. Applicant: Lake Medical Products, Inc..

Clearance details

Applicant: Lake Medical Products, Inc.
Product code: Code FNM
Advisory panel: General Hospital
Date received: 1994-07-01
Decision date: 1995-02-27
Decision: Substantially Equivalent
Clearance type: Traditional
Location: North Brunswick, NJ, 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.