The following data is part of a premarket notification filed by Verily Life Sciences Llc with the FDA for Study Watch.
Device ID | K182456 |
510k Number | K182456 |
Device Name: | Study Watch |
Classification | Transmitters And Receivers, Electrocardiograph, Telephone |
Applicant | Verily Life Sciences LLC 269 E Grand Avenue South San Francisco, CA 94080 |
Contact | Shilpa Mydur |
Correspondent | Shilpa Mydur 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 | 2018-09-07 |
Decision Date | 2019-01-17 |
Summary: | summary |