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, Partial Pressure, Blood-Phase, Indwelling
510(k) Number K961790
Device Name POINT-OF-CARE BLOOD GAS MONITOR SYSTEM
Applicant
Optical Sensors, Inc.
7615 Golden Triangle Dr.,
Suite A
Eden Prairie,  MN  55344
Applicant Contact DENISE A SSCHOTTLER
Correspondent
Optical Sensors, Inc.
7615 Golden Triangle Dr.,
Suite A
Eden Prairie,  MN  55344
Correspondent Contact DENISE A SSCHOTTLER
Regulation Number868.1150
Classification Product Code
CCC  
Subsequent Product Codes
CBZ   CCE  
Date Received05/09/1996
Decision Date 04/09/1997
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-