510(k) K152139

Vital Connect Platform, HealthPatch MD, VitalPatch by Vitalconnect, Inc. — Product Code DRG

K152139 is an FDA 510(k) premarket notification submitted by Vitalconnect, Inc. for the device "Vital Connect Platform, HealthPatch MD, VitalPatch". The FDA issued a decision of Substantially Equivalent on December 6, 2015. The device falls under product code DRG (Transmitters And Receivers, Physiological Signal, Radiofrequency), a Class II device regulated under 21 CFR 870.2910. Vitalconnect, Inc. has at least 9 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 6, 2015
Date Received
August 3, 2015
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