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FDA 510(k), K872962, BREAST-SCAN(TM)
FDA 510(k), K872962, BREAST-SCAN(TM)
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510(K) Number: K872962
Device Name: BREAST-SCAN(TM)
Manufacturer: THERMASCAN, INC.
Device Classification Name: system, thermographic, liquid crystal
Regulation Number: 884.2982
Classification Product Code: LHM
Date Received: 07/29/1987
Decision Date: 10/20/1987
Regulation Medical Specialty: Obstetrics/Gynecology
Device Name: BREAST-SCAN(TM)
Manufacturer: THERMASCAN, INC.
Device Classification Name: system, thermographic, liquid crystal
Regulation Number: 884.2982
Classification Product Code: LHM
Date Received: 07/29/1987
Decision Date: 10/20/1987
Regulation Medical Specialty: Obstetrics/Gynecology
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- Status: Pending Fast-Track Request
- Delivery: Approximately 1 to 2 weeks
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