CPAP MASK— 510(k) K071915

Substantially Equivalent

Arcimed Laboratories, LLC

FDA 510(k) clearance K071915 for CPAP MASK, Substantially Equivalent on 2008-05-14. Applicant: Arcimed Laboratories, LLC.

Clearance details

Applicant: Arcimed Laboratories, LLC
Product code: Code BZD
Advisory panel: Anesthesiology
Date received: 2007-07-11
Decision date: 2008-05-14
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Bonita Springs, FL, US

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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.