BREATHE CPAP SYSTEM— 510(k) K130037

Name: FDA 510(k) clearance K130037
Creator: U.S. Food and Drug Administration
Published: 2013-05-17

Substantially Equivalent

Breathe Technologies, Inc.

FDA 510(k) clearance K130037 for BREATHE CPAP SYSTEM, Substantially Equivalent on 2013-05-17. Applicant: Breathe Technologies, Inc.. Device class: 2.

Clearance details

Applicant: Breathe Technologies, Inc.
Product code: Code BZD
Device class: Class 2
Regulation: 21 CFR 868.5905
Advisory panel: Anesthesiology
Date received: 2013-01-07
Decision date: 2013-05-17
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Irvine, CA, US

Download summary PDF View on FDA.gov ↗

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Adverse events under product code BZD

product code BZD

Death: 4,440
Injury: 53,099
Malfunction: 213,222
Other: 17
Total: 270,778

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.