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 K010187
Device Name KIMAX, MODEL 1024
Applicant
Medical Metrics, Inc.
4600 N. Park Ave.
Suite 100
Chevy Chase,  MD  20815 -4518
Applicant Contact ANN TUNSTALL
Correspondent
Medical Metrics, Inc.
4600 N. Park Ave.
Suite 100
Chevy Chase,  MD  20815 -4518
Correspondent Contact ANN TUNSTALL
Regulation Number892.1650
Classification Product Code
JAA  
Date Received01/22/2001
Decision Date 02/14/2001
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Type Abbreviated
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-