Clearance Summary
Spire Health Remote Patient Monitoring System received FDA 510(k) clearance under submission number K192952, sponsored by Spire, Inc. D/B/A Spire Health. The device was reviewed via the Traditional premarket notification pathway and assigned to the Cardiovascular review panel. The statutory decision date of record is 2020-06-05.
- Submission: K192952
- Applicant / Sponsor: Spire, Inc. D/B/A Spire Health
- Clearance pathway: Traditional
- Review panel: Cardiovascular
- Device class: Class II
- Regulation citation: 21 CFR 870.2300
- Decision date: 2020-06-05
Classification & Regulation
This clearance is catalogued under FDA product code MSX and 21 CFR 870.2300, within the Cardiovascular review panel as a Class II device.