VitalPatch® VitalConnect Platform

Transmitters And Receivers, Physiological Signal, Radiofrequency

VITAL CONNECT, INC.

The following data is part of a premarket notification filed by Vital Connect, Inc. with the FDA for Vitalpatch® Vitalconnect Platform.

Pre-market Notification Details

• Device ID: K163453
• 510k Number: K163453
• Device Name: VitalPatch® VitalConnect Platform
• Classification: Transmitters And Receivers, Physiological Signal, Radiofrequency
• Applicant: VITAL CONNECT, INC. 900 E. HAMILTON AVENUE SUITE 500 Campbell, CA 95008
• Contact: Kevin Potgieter
• Correspondent: Kevin Potgieter; VITAL CONNECT, INC. 900 E. HAMILTON AVENUE SUITE 500 Campbell, CA 95008
• Product Code: DRG
• Subsequent Product Code: DSI
• Subsequent Product Code: MHX
• CFR Regulation Number: 870.2910 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2016-12-09
• Decision Date: 2017-11-02
• Summary: summary