The following data is part of a premarket notification filed by Airway Management, Inc. with the FDA for Tap Pap Nasal Pillow Mask.
| Device ID | K122350 |
| 510k Number | K122350 |
| Device Name: | TAP PAP NASAL PILLOW MASK |
| Classification | Ventilator, Non-continuous (respirator) |
| Applicant | AIRWAY MANAGEMENT, INC. 24301 WOODSAGE DRIVE Bonita Springs, FL 34134 |
| Contact | Paul Dryden |
| Correspondent | Paul Dryden AIRWAY MANAGEMENT, INC. 24301 WOODSAGE DRIVE Bonita Springs, FL 34134 |
| Product Code | BZD |
| CFR Regulation Number | 868.5905 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2012-08-03 |
| Decision Date | 2012-11-01 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00851085006131 | K122350 | 000 |
| 00851085006025 | K122350 | 000 |
| 00851085006018 | K122350 | 000 |