LUNA CPAP AND AUTO-CPAP SYSTEM— 510(k) K141770

Substantially Equivalent

3B Medical, Inc.

FDA 510(k) clearance K141770 for LUNA CPAP AND AUTO-CPAP SYSTEM, Substantially Equivalent on 2015-04-22. Applicant: 3B Medical, Inc..

Clearance details

Applicant: 3B Medical, Inc.
Product code: Code BZD
Advisory panel: Anesthesiology
Date received: 2014-07-01
Decision date: 2015-04-22
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Lake Wales, 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.