The following data is part of a premarket notification filed by Securus Medical Group, Inc. with the FDA for Ats Thermal Imaging Probe, Ats Patient Interface Unit.
| Device ID | K180148 |
| 510k Number | K180148 |
| Device Name: | ATS Thermal Imaging Probe, ATS Patient Interface Unit |
| Classification | Thermometer, Electronic, Clinical |
| Applicant | Securus Medical Group, Inc. 100 Cummings Center, Suite 215F Beverly, MA 01915 |
| Contact | William J. Gorman |
| Correspondent | William J. Gorman Securus Medical Group, Inc. 100 Cummings Center, Suite 215F Beverly, MA 01915 |
| Product Code | FLL |
| CFR Regulation Number | 880.2910 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2018-01-19 |
| Decision Date | 2018-03-21 |
| Summary: | summary |