510(k) K832731
K832731 is an FDA 510(k) premarket notification submitted by American Thermal Instruments, Inc. for the device "BREAST & BODY HEALTH SYSTEM 2000". The FDA issued a decision of Substantially Equivalent on January 30, 1984. The device falls under product code KXZ (System, Thermographic, Liquid Crystal, Powered (Adjunctive Use)), a Class III device regulated under 21 CFR 884.2982. American Thermal Instruments, Inc. has at least 1 other 510(k) clearance on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- January 30, 1984
- Date Received
- August 4, 1983
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- System, Thermographic, Liquid Crystal, Powered (Adjunctive Use)
- Device Class
- Class III
- Regulation Number
- 884.2982
- Review Panel
- RA
- Submission Type