The following data is part of a premarket notification filed by Apieron, Inc. with the FDA for Apieron Insight Eno System.
| Device ID | K083617 |
| 510k Number | K083617 |
| Device Name: | APIERON INSIGHT ENO SYSTEM |
| Classification | System, Test, Breath Nitric Oxide |
| Applicant | APIERON, INC. 155 JEFFERSON DRIVE Menlo Park, CA 94025 |
| Contact | Nina Peled |
| Correspondent | Nina Peled APIERON, INC. 155 JEFFERSON DRIVE Menlo Park, CA 94025 |
| Product Code | MXA |
| CFR Regulation Number | 862.3080 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2008-12-08 |
| Decision Date | 2009-01-27 |
| Summary: | summary |