FDA 510(k) Application Details - K041397

Device Classification Name	Transducer, Ultrasonic, Diagnostic   More FDA Info for this Device
510(K) Number	K041397
Device Name	Transducer, Ultrasonic, Diagnostic
Applicant	PENTAX PRECISION INSTRUMENT CORP. 30 RAMLAND RD. ORANGEBURG, NY 10962 US Other 510(k) Applications for this Company
Contact	PAUL SILVA 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	05/26/2004
Decision Date	06/09/2004
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	Y
Expedited Review