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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 CUTANEOUS PCO2 MONITOR
Generic NameMONITOR, CARBON-DIOXIDE, CUTANEOUS
Regulation Number868.2480
ApplicantKontron Cardiovascular
9 Plymouth St.
Everett, MA 02149
PMA NumberP810037
Supplement NumberS007
Date Received09/18/1996
Decision Date11/25/1997
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 modification of MicroGas 7640 with COMBI 81. The device, as modified, will be marketed under the trade name MicroGas 7650 with COMBI M82.
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