FDA 510(k) Application Details - K974468

Device Classification Name	Lamp, Infrared, Therapeutic Heating   More FDA Info for this Device
510(K) Number	K974468
Device Name	Lamp, Infrared, Therapeutic Heating
Applicant	BALES SCIENTIFIC, INC. 1620 TICE VALLEY BLVD., #250 WALNUT CREEK, CA 94595 US Other 510(k) Applications for this Company
Contact	MAURICE BALES Other 510(k) Applications for this Contact
Regulation Number	890.5500   More FDA Info for this Regulation Number
Classification Product Code	ILY Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	11/26/1997
Decision Date	06/22/1998
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	PM - Physical Medicine
Review Advisory Committee	PM - Physical Medicine
Statement / Summary / Purged Status	Statement
Type	Traditional
Reviewed By Third Party	N
Expedited Review