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 Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase
510(k) Number K900979
Device Name GAS SAMPLING NASAL CANNULA
Applicant
Gibeck, Inc.
10640 E. 59th St.
P.O. Box 36430
Indianapolis,  IN  46236
Applicant Contact RICK HARTNETT
Correspondent
Gibeck, Inc.
10640 E. 59th St.
P.O. Box 36430
Indianapolis,  IN  46236
Correspondent Contact RICK HARTNETT
Regulation Number868.1400
Classification Product Code
CCK  
Date Received03/02/1990
Decision Date 03/16/1990
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-