The following data is part of a premarket notification filed by Abeon Medical Corporation with the FDA for Intelair Nasal Airway Support System.
| Device ID | K142467 |
| 510k Number | K142467 |
| Device Name: | IntelAir Nasal Airway Support System |
| Classification | Analyzer, Gas, Carbon-dioxide, Gaseous-phase |
| Applicant | ABEON MEDICAL CORPORATION 8000 KATHERINE BOULEVARD Brecksville, OH 44141 |
| Contact | Allison Slaga |
| Correspondent | Allison Slaga ABEON MEDICAL CORPORATION 8000 KATHERINE BOULEVARD Brecksville, OH 44141 |
| Product Code | CCK |
| CFR Regulation Number | 868.1400 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2014-09-03 |
| Decision Date | 2014-11-24 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00842071132033 | K142467 | 000 |
| 00842071132026 | K142467 | 000 |
| 00842071131937 | K142467 | 000 |
| 00842071132002 | K142467 | 000 |
| 00842071131999 | K142467 | 000 |
| 00842071131982 | K142467 | 000 |
| 00842071131975 | K142467 | 000 |
| 00842071131968 | K142467 | 000 |