FDA 510(k) Application Details - K011955

Device Classification Name	Diathermy, Ultrasonic, For Use In Applying Therapeutic Deep Heat   More FDA Info for this Device
510(K) Number	K011955
Device Name	Diathermy, Ultrasonic, For Use In Applying Therapeutic Deep Heat
Applicant	METRON MEDICAL AUSTRALIA PTY LTD 57 ASTER AVE. CARRUM DOWNS, VICTORIA 3201 AU Other 510(k) Applications for this Company
Contact	ROB HOPKINS Other 510(k) Applications for this Contact
Regulation Number	890.5300   More FDA Info for this Regulation Number
Classification Product Code	IMI Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	06/22/2001
Decision Date	07/16/2001
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	PM - Physical Medicine
Review Advisory Committee	PM - Physical Medicine
Statement / Summary / Purged Status	Statement
Type	Special
Reviewed By Third Party	N
Expedited Review