CUTANIOUS GAS MONITOR

FDA Premarket Approval P830008 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

DeviceCUTANIOUS GAS MONITOR
Generic NameMonitor, Carbon-dioxide, Cutaneous
ApplicantSENSORMEDICS CORP.
Date Received1984-10-23
Decision Date1985-01-11
PMAP830008
SupplementS002
Product CodeLKD 
Advisory CommitteeCardiovascular
Expedited ReviewNo
Combination Product No
Applicant Address SENSORMEDICS CORP. 1630 S. State College Blvd. anaheim, CA 92806

Supplemental Filings

Supplement NumberDateSupplement Type
P830008Original Filing
S003 1984-11-06
S002 1984-10-23
S001 1984-02-16

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