The following data is part of a premarket notification filed by 3b Medical, Inc with the FDA for 3b Resmart Bpap 25a, Bmc Resmart Bpap 25a.
| Device ID | K133769 |
| 510k Number | K133769 |
| Device Name: | 3B RESMART BPAP 25A, BMC RESMART BPAP 25A |
| Classification | Ventilator, Non-continuous (respirator) |
| Applicant | 3B MEDICAL, INC 21301 HWY 27 N Lake Wales, FL 33859 |
| Contact | Alex Lucio |
| Correspondent | Alex Lucio 3B MEDICAL, INC 21301 HWY 27 N 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 | 2013-12-11 |
| Decision Date | 2014-08-25 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 06948538365151 | K133769 | 000 |
| 06948538365144 | K133769 | 000 |
| 16948538362034 | K133769 | 000 |