• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Premarket Approval (PMA)

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC | Inspections
 


New Search Back to Search Results
 
Trade NameKONTRON KOLORMON PLUS BLOODGAS MODULE 7267505
Classification Namemonitor, carbon-dioxide, cutaneous
Generic Namecutaneous co2 monitor
Regulation Number868.2480
ApplicantKONTRON INSTRUMENTS LTD.
PMA NumberP810037
Supplement NumberS010
Date Received03/14/1997
Decision Date05/22/1998
Product Code
LKD[ Registered Establishments with LKD ]
Advisory Committee Anesthesiology
Supplement Typenormal 180 day track
Supplement Reason change design/components/specifications - other
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for converstion of the stand-alone microgas 7640 p02/pc02 monitor to a plug-in module for the kolormon plus host. The device, as modified, will be marketed under the trade name kontron kolormon plus bloodgas module 7267-505 and is indicated for cutaneous measurement of blood gas tensions (p02 or pc02).
-
-