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 X-Ray, Tomography, Computed, Dental
510(k) Number K003787
Device Name NEWTOM QR-DVT 9000
Applicant
APERIO SERVICES, LLC
815 CONNECTICUT AVENUE, NW
WASHINGTON,,  DC  20006 -4078
Applicant Contact GREGORY W BOWMAN
Correspondent
APERIO SERVICES, LLC
815 CONNECTICUT AVENUE, NW
WASHINGTON,,  DC  20006 -4078
Correspondent Contact GREGORY W BOWMAN
Regulation Number892.1750
Classification Product Code
OAS  
Date Received12/08/2000
Decision Date 03/08/2001
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Type Traditional
Reviewed by Third Party No
Combination Product No
-
-