The following data is part of a premarket notification filed by Ag Digital Technology Corp. with the FDA for Ag Thermographic Camera, Model Atir-m301.
| Device ID | K101641 |
| 510k Number | K101641 |
| Device Name: | AG THERMOGRAPHIC CAMERA, MODEL ATIR-M301 |
| Classification | System, Telethermographic (adjunctive Use) |
| Applicant | AG DIGITAL TECHNOLOGY CORP. 2904 N. BOLDT DRIVE Flagstaff, AZ 86001 |
| Contact | Jennifer Reich |
| Correspondent | Jennifer Reich AG DIGITAL TECHNOLOGY CORP. 2904 N. BOLDT DRIVE Flagstaff, AZ 86001 |
| Product Code | LHQ |
| CFR Regulation Number | 884.2980 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2010-06-10 |
| Decision Date | 2011-06-16 |
| Summary: | summary |