The following data is part of a premarket notification filed by Spirosure, Inc. with the FDA for Fenom Pro Nitric Oxide Test.
| Device ID | K182874 |
| 510k Number | K182874 |
| Device Name: | Fenom Pro Nitric Oxide Test |
| Classification | System, Test, Breath Nitric Oxide |
| Applicant | Spirosure, Inc. 7020 Koll Center Parkway, Suite 110 Pleasanton, CA 94566 |
| Contact | Ryan Leard |
| Correspondent | Erika Ammirati Ammirati Regulatory Consulting 575 Shirlynn Court Los Altos, CA 94022 |
| Product Code | MXA |
| CFR Regulation Number | 862.3080 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2018-10-12 |
| Decision Date | 2019-02-13 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00860008017956 | K182874 | 000 |
| 00860008017949 | K182874 | 000 |
| 00860008017932 | K182874 | 000 |
| 00860008017925 | K182874 | 000 |
| 00860008017918 | K182874 | 000 |
| 00860008017901 | K182874 | 000 |