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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.
 
DeviceLIFESPAN(TM) 100 TCPCO2 MONITOR
Generic NameMONITOR, CARBON-DIOXIDE, CUTANEOUS
Regulation Number868.2480
ApplicantBiochem International, Inc.
10238 N. 1650 Rockwood Dr.
Waukesha, WI 53186
PMA NumberP820019
Supplement NumberS005
Date Received12/11/1984
Decision Date11/19/1985
Product Code LKD 
Advisory Committee Cardiovascular
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
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