The following data is part of a premarket notification filed by Vital Connect Inc. with the FDA for Vitalconnect Platform (consisting Of Vitalconnect Sensor, Relay Software Library And Secure Server Software Library).
Device ID | K141167 |
510k Number | K141167 |
Device Name: | VITALCONNECT PLATFORM (CONSISTING OF VITALCONNECT SENSOR, RELAY SOFTWARE LIBRARY AND SECURE SERVER SOFTWARE LIBRARY) |
Classification | Transmitters And Receivers, Physiological Signal, Radiofrequency |
Applicant | VITAL CONNECT INC. 900 E. HAMILTON AVE., SUITE 500 Campbell, CA 95008 |
Contact | Sam Mostafavi |
Correspondent | Sam Mostafavi VITAL CONNECT INC. 900 E. HAMILTON AVE., 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 | 2014-05-06 |
Decision Date | 2014-07-29 |
Summary: | summary |