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U.S. Department of Health and Human Services

Premarket Approval (PMA)

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Trade NameKONTRON CUTANEOUS PCO2 MONITOR
Classification Namemonitor, carbon-dioxide, cutaneous
Generic Namecutaneous co2 monitor
Regulation Number868.2480
ApplicantKONTRON CARDIOVASCULAR
PMA NumberP810037
Supplement NumberS007
Date Received09/18/1996
Decision Date11/25/1997
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 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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