The following data is part of a premarket notification filed by Spire, Inc. D/b/a Spire Health with the FDA for Spire Health Remote Patient Monitoring System.
| Device ID | K192952 |
| 510k Number | K192952 |
| Device Name: | Spire Health Remote Patient Monitoring System |
| Classification | System, Network And Communication, Physiological Monitors |
| Applicant | Spire, Inc. D/b/a Spire Health 2030 Harrison St San Francisco, CA 94110 |
| Contact | Joanne Hollenbach |
| Correspondent | Jared Seehafer Enzyme Corporation 360 Langton St, Ste 100 San Francisco, CA 94103 |
| Product Code | MSX |
| CFR Regulation Number | 870.2300 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2019-10-21 |
| Decision Date | 2020-06-05 |