The following data is part of a premarket notification filed by Verily Life Sciences Llc with the FDA for Study Watch With Irregular Pulse Monitor.
| Device ID | K192415 |
| 510k Number | K192415 |
| Device Name: | Study Watch With Irregular Pulse Monitor |
| Classification | Transmitters And Receivers, Electrocardiograph, Telephone |
| Applicant | Verily Life Sciences LLC 269 E Grand Avenue South San Francisco, CA 94080 |
| Contact | Connie Pascual |
| Correspondent | Richard M. Stewart Verily Life Sciences LLC 269 E Grand Avenue South San Francisco, CA 94080 |
| Product Code | DXH |
| CFR Regulation Number | 870.2920 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2019-09-04 |
| Decision Date | 2020-01-17 |