FDA 510(k), K032350, INFRARED SCIENCES BREASTSCAN IR SYSTEM
FDA 510(k), K032350, INFRARED SCIENCES BREASTSCAN IR SYSTEM
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510(K) Number: K032350
Device Name: INFRARED SCIENCES BREASTSCAN IR SYSTEM
Manufacturer:
Device Classification Name: System, Telethermographic (Adjunctive Use)
Regulation Number: 884.2980
Classification Product Code: LHQ
Date Received: 07/30/2003
Decision Date: 02/20/2004
Regulation Medical Specialty: Obstetrics/Gynecology
Device Name: INFRARED SCIENCES BREASTSCAN IR SYSTEM
Manufacturer:
Device Classification Name: System, Telethermographic (Adjunctive Use)
Regulation Number: 884.2980
Classification Product Code: LHQ
Date Received: 07/30/2003
Decision Date: 02/20/2004
Regulation Medical Specialty: Obstetrics/Gynecology