The following data is part of a premarket notification filed by Intouch Health, Inc. with the FDA for Remote Presence System, Model Rp-vita.
Device ID | K123229 |
510k Number | K123229 |
Device Name: | REMOTE PRESENCE SYSTEM, MODEL RP-VITA |
Classification | Transmitters And Receivers, Physiological Signal, Radiofrequency |
Applicant | INTOUCH HEALTH, INC. 6330 HOLLISTER AVE. Goleta, CA 93117 |
Contact | Steve Sidwell |
Correspondent | Steve Sidwell INTOUCH HEALTH, INC. 6330 HOLLISTER AVE. Goleta, CA 93117 |
Product Code | DRG |
CFR Regulation Number | 870.2910 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2012-10-15 |
Decision Date | 2012-11-20 |
Summary: | summary |
Device Identifier | submissionNumber | Supplement |
---|---|---|
00868772000105 | K123229 | 000 |