510(k) K132447

VITALCONNECT PLATFORM BY VITAL CONNECT INC. by Vitalconnect, Inc. — Product Code DRG

K132447 is an FDA 510(k) premarket notification submitted by Vitalconnect, Inc. for the device "VITALCONNECT PLATFORM BY VITAL CONNECT INC.". The FDA issued a decision of Substantially Equivalent on April 3, 2014. 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
April 3, 2014
Date Received
August 6, 2013
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