The following data is part of a premarket notification filed by Puritan Bennett Corp. with the FDA for Companion 318 Nasal Cpap System -- Modification.
| Device ID | K922178 |
| 510k Number | K922178 |
| Device Name: | COMPANION 318 NASAL CPAP SYSTEM -- MODIFICATION |
| Classification | Attachment, Breathing, Positive End Expiratory Pressure |
| Applicant | PURITAN BENNETT CORP. 10800 PFLUMM RD. Lenexa, KS 66215 |
| Contact | Marshall Smith |
| Correspondent | Marshall Smith PURITAN BENNETT CORP. 10800 PFLUMM RD. Lenexa, KS 66215 |
| Product Code | BYE |
| CFR Regulation Number | 868.5965 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1992-05-08 |
| Decision Date | 1992-05-29 |