The following data is part of a premarket notification filed by Respironics, Inc. with the FDA for Respironics Pr Valve.
| Device ID | K833327 |
| 510k Number | K833327 |
| Device Name: | RESPIRONICS PR VALVE |
| Classification | Cuff, Tracheal Tube, Inflatable |
| Applicant | RESPIRONICS, INC. 530 SECO RD. Monroeville, PA 15146 |
| Product Code | BSK |
| CFR Regulation Number | 868.5750 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1983-09-27 |
| Decision Date | 1983-11-28 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 50351688517171 | K833327 | 000 |