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

Name: FDA 510(k) clearance K943162
Creator: U.S. Food and Drug Administration
Published: 1995-02-27

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.. Device class: 2.

Clearance details

Applicant: Lake Medical Products, Inc.
Product code: Code FNM
Device class: Class 2
Regulation: 21 CFR 880.5550
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

Download summary PDF View on FDA.gov ↗

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More clearances from Lake Medical Products, Inc.

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K922730 — LAKE OSTOMY CARE SET1993-12-30
K905053 — STAGE ZERO AIR FLOTATION BED1990-11-26
K901835 — LAKE N/G FEEDING TUBE (WITH Y PORT CONNECTOR)1990-09-05
K902508 — LAKE MALE EXTERNAL CATHETERIZATION KIT1990-08-23
K902121 — LAKE GASTROSTOMY TUBE1990-07-27

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.