CERAMATEC MAXCELL AND CAG GALVANIC OXYGEN SENSORS

Analyzer, Gas, Oxygen, Gaseous-phase

CERAMATEC, INC.

The following data is part of a premarket notification filed by Ceramatec, Inc. with the FDA for Ceramatec Maxcell And Cag Galvanic Oxygen Sensors.

Pre-market Notification Details

Device IDK972992
510k NumberK972992
Device Name:CERAMATEC MAXCELL AND CAG GALVANIC OXYGEN SENSORS
ClassificationAnalyzer, Gas, Oxygen, Gaseous-phase
Applicant CERAMATEC, INC. 2425 SOUTH 900 WEST Salt Lake City,  UT  84119
ContactGordon Roth
CorrespondentGordon Roth
CERAMATEC, INC. 2425 SOUTH 900 WEST Salt Lake City,  UT  84119
Product CodeCCL  
CFR Regulation Number868.1720 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1997-08-12
Decision Date1998-03-30
Summary:summary

NIH GUDID Devices

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