The following data is part of a premarket notification filed by Cohero Health Llc with the FDA for Spirothor.
| Device ID | K150137 |
| 510k Number | K150137 |
| Device Name: | SpiroThor |
| Classification | Spirometer, Diagnostic |
| Applicant | Cohero Health LLC 335 Madison Avenue, 3rd Floor New York, NY 10017 |
| Contact | Melissa Manice |
| Correspondent | Paul Dryden Cohero Health LLC 335 Madison Avenue, 3rd Floor New York, NY 10017 |
| Product Code | BZG |
| CFR Regulation Number | 868.1840 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2015-01-22 |
| Decision Date | 2015-05-27 |
| Summary: | summary |