The following data is part of a premarket notification filed by Puritan-bennett with the FDA for Puritan-bennett Nasal Cpap Mask.
| Device ID | K942246 |
| 510k Number | K942246 |
| Device Name: | PURITAN-BENNETT NASAL CPAP MASK |
| Classification | Attachment, Breathing, Positive End Expiratory Pressure |
| Applicant | PURITAN-BENNETT 10800 PFLUMM RD. Lenexa,, KS 66215 |
| Contact | Marshall C Smith |
| Correspondent | Marshall C Smith PURITAN-BENNETT 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 | 1994-05-09 |
| Decision Date | 1994-07-06 |