The following data is part of a premarket notification filed by Intouch Health, Inc. with the FDA for Remote Presence System.
| Device ID | K120895 |
| 510k Number | K120895 |
| Device Name: | REMOTE PRESENCE SYSTEM |
| 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 | 2012-03-23 |
| Decision Date | 2012-05-24 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00868772000181 | K120895 | 000 |
| 00868772000150 | K120895 | 000 |
| 00868772000143 | K120895 | 000 |
| 00868772000136 | K120895 | 000 |
| 00868772000112 | K120895 | 000 |
| 00860000825818 | K120895 | 000 |