Luna CPAP and Auto CPAP System— 510(k) K153387
Substantially Equivalent3B Medical, Inc.
FDA 510(k) clearance K153387 for Luna CPAP and Auto CPAP System, Substantially Equivalent on 2016-09-08. Applicant: 3B Medical, Inc.. Device class: 2.
Clearance details
- Applicant
- 3B Medical, Inc.
- Product code
- Code BZD
- Device class
- Class 2
- Regulation
- 21 CFR 868.5905
- Advisory panel
- Anesthesiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Lake Wales, FL, US
Recent devices under product code BZD
view allMore clearances from 3B Medical, Inc.
view allAdverse 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, through . 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.