FDA 510(k) Application Details - K011284

Device Classification Name	Transducer, Ultrasonic, Diagnostic   More FDA Info for this Device
510(K) Number	K011284
Device Name	Transducer, Ultrasonic, Diagnostic
Applicant	MARTIN E. WENDELKEN 610 BLVD. ELMWOOD PARK, NJ 07407 US Other 510(k) Applications for this Company
Contact	MARTIN E WENDELKEN Other 510(k) Applications for this Contact
Regulation Number	892.1570   More FDA Info for this Regulation Number
Classification Product Code	ITX Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	04/27/2001
Decision Date	06/20/2001
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	RA - Radiology
Review Advisory Committee	RA - Radiology
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review