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U.S. Department of Health and Human Services

Premarket Approval (PMA)
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Note: This medical device record is a PMA supplement. A supplement may have changed the device description/function or indication from that approved in the original PMA. Be sure to look at the original PMA record for more information.
 
DeviceKONTRON KOLORMON PLUS BLOODGAS MODULE 7267505
Generic NameMONITOR, CARBON-DIOXIDE, CUTANEOUS
Regulation Number868.2480
ApplicantKontron Cardiovascular
9 Plymouth St.
Everett, MA 02149
PMA NumberP810037
Supplement NumberS010
Date Received03/14/1997
Decision Date05/22/1998
Product Code LKD 
Advisory Committee Anesthesiology
Supplement TypeNormal 180 Day Track
Supplement Reason Change Design/Components/Specifications/Material
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
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).
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