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 System, X-Ray, Fluoroscopic, Image-Intensified
510(k) Number K870429
Device Name EUSEK-BUSH IN-BATH FILMING DEVICE (#MC-00186)
Applicant
The Mason Clinic
1100 Ninth Ave.
P.O. Box 900
Seattle,  WA  98111
Applicant Contact EUSEK, R.T.
Correspondent
The Mason Clinic
1100 Ninth Ave.
P.O. Box 900
Seattle,  WA  98111
Correspondent Contact EUSEK, R.T.
Regulation Number892.1650
Classification Product Code
JAA  
Date Received02/05/1987
Decision Date 02/11/1987
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
-
-