K141770 is an FDA 510(k) clearance for the LUNA CPAP AND AUTO-CPAP SYSTEM. This device is classified as a Ventilator, Non-continuous (respirator) (Class II - Special Controls, product code BZD).
Submitted by 3B Medical, Inc. (Lake Wales, US). The FDA issued a Cleared decision on April 22, 2015, 295 days after receiving the submission on July 1, 2014.
This device falls under the Anesthesiology FDA review panel. Regulated under 21 CFR 868.5905.
| 510(k) Number | K141770 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | July 01, 2014 |
| Decision Date | April 22, 2015 |
| Days to Decision | 295 days |
| Submission Type | Traditional |
| Review Panel | Anesthesiology (AN) |
| Summary | Summary PDF |
| Product Code | BZD - Ventilator, Non-continuous (respirator) |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 868.5905 |