The following data is part of a premarket notification filed by Multisensor Diagnostics (dba Aidar Health) with the FDA for Mouthlab Vital Signs Monitoring System.
| Device ID | K201635 |
| 510k Number | K201635 |
| Device Name: | MouthLab Vital Signs Monitoring System |
| Classification | Monitor, Physiological, Patient (without Arrhythmia Detection Or Alarms) |
| Applicant | MultiSensor Diagnostics (dba Aidar Health) 3402 Birch Hollow Rd. Pikesville, MD 21208 |
| Contact | Sathya Elumalai |
| Correspondent | Allison C. Komiyama AcKnowledge Regulatory Strategies, LLC 2251 San Diego Ave, Suite B-257 San Diego, CA 92110 |
| Product Code | MWI |
| Subsequent Product Code | BZH |
| Subsequent Product Code | BZQ |
| Subsequent Product Code | DPS |
| Subsequent Product Code | DQA |
| Subsequent Product Code | DXN |
| Subsequent Product Code | FLL |
| CFR Regulation Number | 870.2300 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2020-06-16 |
| Decision Date | 2021-02-06 |