The following data is part of a premarket notification filed by Nuvoair Ab with the FDA for Air Next.
| Device ID | K183089 |
| 510k Number | K183089 |
| Device Name: | Air Next |
| Classification | Spirometer, Diagnostic |
| Applicant | NuvoAir AB 17D Riddargatan Stockholm, SE 11457 |
| Contact | Max Ladow |
| Correspondent | Yolanda Smith Smith Associates 1468 Harwell Ave Crofton, MD 21114 |
| Product Code | BZG |
| CFR Regulation Number | 868.1840 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2018-11-06 |
| Decision Date | 2020-01-02 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 17350002630027 | K183089 | 000 |