510(k) K852950
K852950 is an FDA 510(k) premarket notification submitted by C.D. Regelin & Associates, Inc. for the device "VISITHERM". The FDA issued a decision of Substantially Equivalent on February 7, 1986. The device falls under product code IYM (System, Telethermographic, Infrared), a Class III device regulated under 21 CFR 884.2980.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- February 7, 1986
- Date Received
- July 11, 1985
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- System, Telethermographic, Infrared
- Device Class
- Class III
- Regulation Number
- 884.2980
- Review Panel
- RA
- Submission Type