DEVILBISS INTELLIPAP/ SLEEPCUBE BILEVEL ST, DV56 ST SERIES— 510(k) K093070

Name: FDA 510(k) clearance K093070
Creator: U.S. Food and Drug Administration
Published: 2010-01-26

Substantially Equivalent

Sunrise Medical

FDA 510(k) clearance K093070 for DEVILBISS INTELLIPAP/ SLEEPCUBE BILEVEL ST, DV56 ST SERIES, Substantially Equivalent on 2010-01-26. Applicant: Sunrise Medical. Device class: 2.

Clearance details

Applicant: Sunrise Medical
Product code: Code MNS
Device class: Class 2
Regulation: 21 CFR 868.5895
Advisory panel: Anesthesiology
Date received: 2009-09-30
Decision date: 2010-01-26
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Somerset, PA, US

Download summary PDF View on FDA.gov ↗

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Adverse events under product code MNS

product code MNS

Death: 344
Injury: 1,160
Malfunction: 8,068
Total: 9,572

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.