The following data is part of a premarket notification filed by Abeon Medical Corporation with the FDA for Airway Support System / Airport.
| Device ID | K131506 |
| 510k Number | K131506 |
| Device Name: | AIRWAY SUPPORT SYSTEM / AIRPORT |
| 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 | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2013-05-24 |
| Decision Date | 2014-03-06 |