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 Calibrator, Dose, Radionuclide
510(k) Number K010417
Device Name CAL/RAD MARK IV-DOSE CALIBRATOR 34-162 VEENSTRA MODEL # VDC-304
Applicant
Nuclear Assoc., Div. Inovision LP
100 Voice Rd.
Carle Place,  NY  11514
Applicant Contact CHRISTINE G CASTLEBERRY
Correspondent
Nuclear Assoc., Div. Inovision LP
100 Voice Rd.
Carle Place,  NY  11514
Correspondent Contact CHRISTINE G CASTLEBERRY
Regulation Number892.1360
Classification Product Code
KPT  
Date Received02/12/2001
Decision Date 04/26/2001
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
-
-