TCO2M MODEL 818 MONITOR

FDA Premarket Approval P810022 S006

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

DeviceTCO2M MODEL 818 MONITOR
Generic NameMonitor, Carbon-dioxide, Cutaneous
ApplicantNOVAMETRIX MEDICAL SYSTEMS, INC.
Date Received1984-06-18
Decision Date1984-09-21
PMAP810022
SupplementS006
Product CodeLKD 
Advisory CommitteeAnesthesiology
Expedited ReviewNo
Combination Product No
Applicant Address NOVAMETRIX MEDICAL SYSTEMS, INC. 1 Barnes Industrial Park Rd. p.o. Box 690 wallingford, CT 06492

Supplemental Filings

Supplement NumberDateSupplement Type
P810022Original Filing
S014 1987-03-03 Normal 180 Day Track
S013 1986-11-03 Normal 180 Day Track
S012 1986-03-31 Normal 180 Day Track
S011 1985-07-12
S010 1985-05-06
S009 1985-02-19
S008 1985-01-07
S007 1984-10-19
S006 1984-06-18
S005 1984-06-04
S004 1984-03-30
S003 1984-03-02
S002
S001 1981-08-06

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