510(k) K192952
K192952 is an FDA 510(k) premarket notification submitted by Spire, Inc. D/B/A Spire Health for the device "Spire Health Remote Patient Monitoring System". The FDA issued a decision of Substantially Equivalent on Jun 5, 2020. The device falls under product code MSX (System, Network And Communication, Physiological Monitors), a Class II device regulated under 21 CFR 870.2300.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Jun 5, 2020
- Date Received
- Oct 21, 2019
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- System, Network And Communication, Physiological Monitors
- Device Class
- Class II
- Regulation Number
- 870.2300
- Review Panel
- CV
- Submission Type
- 510(k)