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 K944196
Device Name IMWXDOP IR
Applicant
Imex Medical Systems, Inc.
6355 Joyce Dr.
Golden,  CO  80403
Applicant Contact DENNIS NEWMAN
Correspondent
Imex Medical Systems, Inc.
6355 Joyce Dr.
Golden,  CO  80403
Correspondent Contact DENNIS NEWMAN
Regulation Number892.1540
Classification Product Code
JAF  
Subsequent Product Code
KNG  
Date Received08/29/1994
Decision Date 05/12/1995
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
-
-