FDA 510(k) Application Details - K213357

Device Classification Name Transmitters And Receivers, Electrocardiograph, Telephone

  More FDA Info for this Device
510(K) Number K213357
Device Name Transmitters And Receivers, Electrocardiograph, Telephone
Applicant Verily Life Sciences LLC
269 East Grand Avenue
South San Francisco, CA 94080 US
Other 510(k) Applications for this Company
Contact Dinesh Puppala
Other 510(k) Applications for this Contact
Regulation Number 870.2920

  More FDA Info for this Regulation Number
Classification Product Code DXH
Other 510(k) Applications for this Device

  More FDA Info for this Product Code
Date Received 10/12/2021
Decision Date 07/19/2022
Decision SESE - SUBST EQUIV
Classification Advisory Committee CV - Cardiovascular
Review Advisory Committee CV - Cardiovascular
Statement / Summary / Purged Status Summary
Type Traditional
Reviewed By Third Party N
Expedited Review



Search | Companies | Product Codes | Device Names | Contacts | Applications | Decisions | Contact