The following data is part of a premarket notification filed by Intouch Technologies, Inc., D.b.a. Intouch Health with the FDA for Intouch Thermal Camera.
| Device ID | K181716 |
| 510k Number | K181716 |
| Device Name: | InTouch Thermal Camera |
| Classification | System, Telethermographic (adjunctive Use) |
| Applicant | InTouch Technologies, Inc., D.b.a. InTouch Health 7402 Hollister Avenue Goleta, CA 93117 |
| Contact | Karen Mullin |
| Correspondent | Karen Mullin InTouch Technologies, Inc., D.b.a. InTouch Health 7402 Hollister Avenue Goleta, CA 93117 |
| Product Code | LHQ |
| CFR Regulation Number | 884.2980 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2018-06-28 |
| Decision Date | 2019-03-25 |