The following data is part of a premarket notification filed by Medhot Thermal Imaging, Inc. with the FDA for Medhot Mti 2000 Thermal Imaging System.
| Device ID | K063047 |
| 510k Number | K063047 |
| Device Name: | MEDHOT MTI 2000 THERMAL IMAGING SYSTEM |
| Classification | System, Telethermographic (adjunctive Use) |
| Applicant | MEDHOT THERMAL IMAGING, INC. 55 Northern Blvd. Suite 200 Great Neck, NY 11021 |
| Contact | Sid Mathur |
| Correspondent | Robert Mosenkis CITECH 5200 BUTLER PIKE Plymouth Meeting, PA 19462 -1298 |
| Product Code | LHQ |
| CFR Regulation Number | 884.2980 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | Yes |
| Combination Product | No |
| Date Received | 2006-10-04 |
| Decision Date | 2006-10-19 |
| Summary: | summary |