510(k) K201635
K201635 is an FDA 510(k) premarket notification submitted by Multisensor Diagnostics (Dba Aidar Health) for the device "MouthLab Vital Signs Monitoring System". The FDA issued a decision of Substantially Equivalent on Feb 6, 2021. The device falls under product code MWI (Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms)), a Class II device regulated under 21 CFR 870.2300.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Feb 6, 2021
- Date Received
- Jun 16, 2020
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms)
- Device Class
- Class II
- Regulation Number
- 870.2300
- Review Panel
- CV
- Submission Type
- 510(k)