ELITE 3 LOW AIR LOSS BED— 510(k) K945042

Name: FDA 510(k) clearance K945042
Creator: U.S. Food and Drug Administration
Published: 1995-03-16

Substantially Equivalent

Pegabus Egerton, Ltd.

FDA 510(k) clearance K945042 for ELITE 3 LOW AIR LOSS BED, Substantially Equivalent on 1995-03-16. Applicant: Pegabus Egerton, Ltd.. Device class: 2.

Clearance details

Applicant: Pegabus Egerton, Ltd.
Product code: Code FNL
Device class: Class 2
Regulation: 21 CFR 880.5100
Advisory panel: General Hospital
Date received: 1994-10-14
Decision date: 1995-03-16
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Kent Br1 3tu, GB

Download summary PDF View on FDA.gov ↗

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K945041 — PARAGON PORTABLE1995-03-16

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.