Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

510(k) Premarket Notification
  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 


New Search Back To Search Results
Device Classification Name Transducer, Ultrasonic
510(k) Number K873674
Device Name SDU-700 PHASED ARRAY SECTOR AND LINEAR SCANNER
Applicant
Shimadzu Corp.
1 Nishinokyo-Kuwabaracho
Nakaygo-Ku
Kyoto City 604 Japan,  JP
Applicant Contact TAKAO SOMEYAMA
Correspondent
Shimadzu Corp.
1 Nishinokyo-Kuwabaracho
Nakaygo-Ku
Kyoto City 604 Japan,  JP
Correspondent Contact TAKAO SOMEYAMA
Regulation Number870.2880
Classification Product Code
JOP  
Date Received09/11/1987
Decision Date 10/07/1988
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-