The following data is part of a premarket notification filed by Med-hot Thermal Imaging Inc. with the FDA for Med-hot Thermal Imaging Systems.
| Device ID | K171928 |
| 510k Number | K171928 |
| Device Name: | Med-Hot Thermal Imaging Systems |
| Classification | System, Telethermographic (adjunctive Use) |
| Applicant | Med-Hot Thermal Imaging Inc. 5120 S. Florida Ave. Suite 301 Lakeland, FL 33813 |
| Contact | Carol Chandler |
| Correspondent | E. J. Smith Smith Associates 1468 Harwell Ave. Crofton, MD 21114 |
| Product Code | LHQ |
| CFR Regulation Number | 884.2980 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2017-06-27 |
| Decision Date | 2017-12-08 |
| Summary: | summary |