NEW SUPPORT SYS. FOR BEDRIDDEN PATIENTS— 510(k) K821185

Name: FDA 510(k) clearance K821185
Creator: U.S. Food and Drug Administration
Published: 1982-09-14

Substantially Equivalent

Dase Co.

FDA 510(k) clearance K821185 for NEW SUPPORT SYS. FOR BEDRIDDEN PATIENTS, Substantially Equivalent on 1982-09-14. Applicant: Dase Co.. Device class: 2.

Clearance details

Applicant: Dase Co.
Product code: Code FNL
Device class: Class 2
Regulation: 21 CFR 880.5100
Advisory panel: General Hospital
Date received: 1982-04-27
Decision date: 1982-09-14
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

Download summary PDF View on FDA.gov ↗

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K982783 — VAIL 1000 ENCLOSED BED1998-10-05
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K974254 — BENEFIT B3--- SERIES1997-12-16

Adverse events under product code FNL

product code FNL

Death: 64
Injury: 728
Malfunction: 10,825
Other: 9
Total: 11,626

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.