510(k) K101641
K101641 is an FDA 510(k) premarket notification submitted by Ag Digital Technology Corp. for the device "AG THERMOGRAPHIC CAMERA, MODEL ATIR-M301". The FDA issued a decision of Substantially Equivalent on June 16, 2011. The device falls under product code LHQ (System, Telethermographic (Adjunctive Use)), a Class I device regulated under 21 CFR 884.2980. Ag Digital Technology Corp. has at least 3 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- June 16, 2011
- Date Received
- June 10, 2010
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- System, Telethermographic (Adjunctive Use)
- Device Class
- Class I
- Regulation Number
- 884.2980
- Review Panel
- RA
- Submission Type