510(k) K201746
K201746 is an FDA 510(k) premarket notification submitted by Remote Diagnostic Technologies Limited for the device "Tempus Pro Patient Monitor". The FDA issued a decision of Substantially Equivalent on Sep 18, 2020. The device falls under product code MHX (Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)), a Class II device regulated under 21 CFR 870.1025.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Sep 18, 2020
- Date Received
- Jun 26, 2020
- Clearance Type
- Special
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)
- Device Class
- Class II
- Regulation Number
- 870.1025
- Review Panel
- CV
- Submission Type
- 510(k)