The following data is part of a premarket notification filed by Airsep Corp. with the FDA for Nitelife Bi-level Cpap.
| Device ID | K943207 |
| 510k Number | K943207 |
| Device Name: | NITELIFE BI-LEVEL CPAP |
| Classification | Ventilator, Non-continuous (respirator) |
| Applicant | AIRSEP CORP. 290 CREEKSIDE DR. Buffalo, NY 14228 |
| Contact | Edward E Vrana |
| Correspondent | Edward E Vrana AIRSEP CORP. 290 CREEKSIDE DR. Buffalo, NY 14228 |
| Product Code | BZD |
| CFR Regulation Number | 868.5905 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1994-07-05 |
| Decision Date | 1996-07-29 |