510(k) K872962
K872962 is an FDA 510(k) premarket notification submitted by Thermascan, Inc. for the device "BREAST-SCAN(TM)". The FDA issued a decision of Substantially Equivalent on October 20, 1987. The device falls under product code LHM (System, Thermographic, Liquid Crystal), a Class I device regulated under 21 CFR 884.2982.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- October 20, 1987
- Date Received
- July 29, 1987
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- System, Thermographic, Liquid Crystal
- Device Class
- Class I
- Regulation Number
- 884.2982
- Review Panel
- RA
- Submission Type