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, Rebreathing, Radionuclide
510(k) Number K914747
Device Name XENON CIRCUIT
Applicant
Gibeck, Inc.
10640 E. 59th St.
P.O. Box 36430
Indianapolis,  IN  46236
Applicant Contact PAUL E DRYDEN
Correspondent
Gibeck, Inc.
10640 E. 59th St.
P.O. Box 36430
Indianapolis,  IN  46236
Correspondent Contact PAUL E DRYDEN
Regulation Number892.1390
Classification Product Code
IYT  
Date Received10/22/1991
Decision Date 02/27/1992
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
-
-