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 Echoencephalograph
510(k) Number K821736
Device Name ECHO-PULSE KM555
Applicant
Rabar, Inc.
111 Oneta Rd.
Rochester,  NY  14617
Applicant Contact BERNARD WEINSTEIN
Correspondent
Rabar, Inc.
111 Oneta Rd.
Rochester,  NY  14617
Correspondent Contact BERNARD WEINSTEIN
Regulation Number882.1240
Classification Product Code
GXW  
Date Received06/14/1982
Decision Date 12/09/1982
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-