The following data is part of a premarket notification filed by Vital Signs, Inc. with the FDA for Endotracheal Cpap Set.
| Device ID | K915277 |
| 510k Number | K915277 |
| Device Name: | ENDOTRACHEAL CPAP SET |
| Classification | Tube, Tracheal (w/wo Connector) |
| Applicant | VITAL SIGNS, INC. 20 CAMPUS RD. Totowa, NJ 07512 |
| Contact | Charles J.klein |
| Correspondent | Charles J.klein VITAL SIGNS, INC. 20 CAMPUS RD. Totowa, NJ 07512 |
| Product Code | BTR |
| CFR Regulation Number | 868.5730 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1991-11-25 |
| Decision Date | 1992-03-20 |