510(k) K222398

Care Team Portal by Vivify Health, Inc. — Product Code DRG

K222398 is an FDA 510(k) premarket notification submitted by Vivify Health, Inc. for the device "Care Team Portal". The FDA issued a decision of Substantially Equivalent on February 6, 2023. The device falls under product code DRG (Transmitters And Receivers, Physiological Signal, Radiofrequency), a Class II device regulated under 21 CFR 870.2910.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 6, 2023
Date Received
August 8, 2022
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Transmitters And Receivers, Physiological Signal, Radiofrequency
Device Class
Class II
Regulation Number
870.2910
Review Panel
CV
Submission Type