FDA 510(k) Application Details - K981397

Device Classification Name System, Imaging, Pulsed Doppler, Ultrasonic

  More FDA Info for this Device
510(K) Number K981397
Device Name System, Imaging, Pulsed Doppler, Ultrasonic
Applicant TOSHIBA AMERICA MEDICAL SYSTEMS, INC.
2441 MICHELLE DR.
P.O. BOX 2068
TUSTIN, CA 92781-2068 US
Other 510(k) Applications for this Company
Contact PAUL BIGGINS
Other 510(k) Applications for this Contact
Regulation Number 892.1550

  More FDA Info for this Regulation Number
Classification Product Code IYN
Other 510(k) Applications for this Device

  More FDA Info for this Product Code
Date Received 04/17/1998
Decision Date 07/31/1998
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



Search | Companies | Product Codes | Device Names | Contacts | Applications | Decisions | Contact