The following data is part of a premarket notification filed by Puritan Bennett Corp. with the FDA for Puritan-bennett Companion Nasal Cpap System.
| Device ID | K952292 |
| 510k Number | K952292 |
| Device Name: | PURITAN-BENNETT COMPANION NASAL CPAP SYSTEM |
| Classification | Ventilator, Non-continuous (respirator) |
| Applicant | PURITAN BENNETT CORP. 9728 PFLUMM RD. P.O.BOX 15915 Lenexa, KS 66215 -5915 |
| Contact | C. Marshall Smith |
| Correspondent | C. Marshall Smith PURITAN BENNETT CORP. 9728 PFLUMM RD. P.O.BOX 15915 Lenexa, KS 66215 -5915 |
| Product Code | BZD |
| CFR Regulation Number | 868.5905 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1995-05-16 |
| Decision Date | 1995-11-13 |