LIFESPAN(TM) MODEL 4110 TCPO2/CO2 MONITORING SYSTE

FDA Premarket Approval P820019 S003

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) MODEL 4110 TCPO2/CO2 MONITORING SYSTE
Generic NameMonitor, Carbon-dioxide, Cutaneous
ApplicantBIOCHEM INTERNATIONAL, INC.
Date Received1984-05-08
Decision Date1985-08-21
PMAP820019
SupplementS003
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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