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, Diagnostic
510(k) Number K981434
Device Name EUP-OL334 LAPARASCOPICPROBE
Applicant
Hitachi Medical Corp. of America
19030 Portos Dr.
Saratoga,  CA  95070
Applicant Contact CHARLES F HOTTINGER
Correspondent
Hitachi Medical Corp. of America
19030 Portos Dr.
Saratoga,  CA  95070
Correspondent Contact CHARLES F HOTTINGER
Regulation Number892.1570
Classification Product Code
ITX  
Date Received04/21/1998
Decision Date 07/27/1998
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-