The following data is part of a premarket notification filed by Salter Labs with the FDA for Cpap Cannulaide.
| Device ID | K143700 |
| 510k Number | K143700 |
| Device Name: | CPAP Cannulaide |
| Classification | Ventilator, Non-continuous (respirator) |
| Applicant | Salter Labs 2365 Camino Vida Roble Carlsbad, CA 92011 |
| Contact | Aurelia Brownridge |
| Correspondent | Aurelia Brownridge Salter Labs 2365 Camino Vida Roble Carlsbad, CA 92011 |
| Product Code | BZD |
| CFR Regulation Number | 868.5905 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2014-12-24 |
| Decision Date | 2015-08-05 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10607411007191 | K143700 | 000 |
| 10607411007184 | K143700 | 000 |
| 10607411007177 | K143700 | 000 |
| 10607411007160 | K143700 | 000 |
| 10607411007153 | K143700 | 000 |
| 10607411007146 | K143700 | 000 |