K201635 is an FDA 510(k) clearance for the MouthLab Vital Signs Monitoring System. This device is classified as a Monitor, Physiological, Patient (without Arrhythmia Detection Or Alarms) (Class II - Special Controls, product code MWI).
Submitted by Multisensor Diagnostics (Dba Aidar Health) (Pikesville, US). The FDA issued a Cleared decision on February 6, 2021, 235 days after receiving the submission on June 16, 2020.
This device falls under the Cardiovascular FDA review panel. Regulated under 21 CFR 870.2300.
| 510(k) Number | K201635 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | June 16, 2020 |
| Decision Date | February 06, 2021 |
| Days to Decision | 235 days |
| Submission Type | Traditional |
| Review Panel | Cardiovascular (CV) |
| Summary | Summary PDF |
| Product Code | MWI - Monitor, Physiological, Patient (without Arrhythmia Detection Or Alarms) |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 870.2300 |