LIFESPAN(TM) 100 TCPCO2 MONITOR

FDA Premarket Approval P820019 S002

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.

Pre-market Approval Supplement Details

DeviceLIFESPAN(TM) 100 TCPCO2 MONITOR
Generic NameMonitor, Carbon-dioxide, Cutaneous
ApplicantBIOCHEM INTERNATIONAL, INC.
Date Received1983-04-18
Decision Date1983-05-26
PMAP820019
SupplementS002
Product CodeLKD 
Advisory CommitteeCardiovascular
Expedited ReviewNo
Combination Product No
Applicant Address BIOCHEM INTERNATIONAL, INC. 10238 N. 1650 Rockwood Dr. waukesha, WI 53186

Supplemental Filings

Supplement NumberDateSupplement Type
P820019Original Filing
S007 1986-01-17
S006 1985-02-15
S005 1984-12-11
S004
S003 1984-05-08
S002 1983-04-18
S001

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