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 |