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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.
 
DeviceTCO2M MODEL 818 MONITOR
Generic NameMONITOR, CARBON-DIOXIDE, CUTANEOUS
Regulation Number868.2480
ApplicantNovametrix Medical Systems, Inc.
1 Barnes Industrial Park Rd.
P.O. Box 690
Wallingford, CT 06492
PMA NumberP810022
Supplement NumberS013
Date Received11/03/1986
Decision Date01/29/1987
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
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