The following data is part of a premarket notification filed by 3b Medical, Inc. with the FDA for Luna Cpap And Auto Cpap System.
| Device ID | K153387 |
| 510k Number | K153387 |
| Device Name: | Luna CPAP And Auto CPAP System |
| Classification | Ventilator, Non-continuous (respirator) |
| Applicant | 3B MEDICAL, INC. 21301 HWY 27 Lake Wales, FL 33859 |
| Contact | Alex Lucio |
| Correspondent | Alex Lucio 3B MEDICAL, INC. 21301 HWY 27 Lake Wales, FL 33859 |
| Product Code | BZD |
| CFR Regulation Number | 868.5905 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2015-11-23 |
| Decision Date | 2016-09-08 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 06948538363188 | K153387 | 000 |
| 06948538363171 | K153387 | 000 |
| 06948538363201 | K153387 | 000 |
| 06948538363195 | K153387 | 000 |