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 Monitor, Ultrasonic, Nonfetal
510(k) Number K844128
Device Name EUB-40
Applicant
Hitachi Medical Corp. of America
50 Prospect Ave.
Tarrytown,  NY  10591
Applicant Contact RICHARD A LONG
Correspondent
Hitachi Medical Corp. of America
50 Prospect Ave.
Tarrytown,  NY  10591
Correspondent Contact RICHARD A LONG
Regulation Number892.1540
Classification Product Code
JAF  
Date Received10/23/1984
Decision Date 02/25/1985
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-