The following data is part of a premarket notification filed by Dynosense Corp. with the FDA for Dynosense Vital Sign Measuring System.
| Device ID | K190090 |
| 510k Number | K190090 |
| Device Name: | DynoSense Vital Sign Measuring System |
| Classification | Monitor, Physiological, Patient (without Arrhythmia Detection Or Alarms) |
| Applicant | DynoSense Corp. 15166 Los Gatos Blvd Los Gatos, CA 95032 |
| Contact | Saeed Azimi |
| Correspondent | Saeed Azimi DynoSense Corp. 15166 Los Gatos Blvd Los Gatos, CA 95032 |
| Product Code | MWI |
| CFR Regulation Number | 870.2300 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2019-01-17 |
| Decision Date | 2019-08-02 |