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

Device IdentifiersubmissionNumberSupplement
00817770020103 K972992 000
00855887006726 K972992 000
00853061006975 K972992 000
00853061006913 K972992 000
00853061006906 K972992 000
00853061006739 K972992 000
00853061006708 K972992 000
00853061006692 K972992 000
00853061006685 K972992 000
00853061006678 K972992 000
00853061006661 K972992 000
00853061006654 K972992 000
00817518020006 K972992 000
00817518020013 K972992 000
00817770020097 K972992 000
00817770020080 K972992 000
00817770020073 K972992 000
00817770020066 K972992 000
00817770020059 K972992 000
00817770020042 K972992 000
00817770020035 K972992 000
00817770020028 K972992 000
00817770020011 K972992 000
00817770020004 K972992 000
00817518020020 K972992 000
00853061006647 K972992 000
00853061006630 K972992 000
00853061006623 K972992 000
00853061006449 K972992 000
00853061006432 K972992 000
00853061006418 K972992 000
00817770022428 K972992 000
00815871020183 K972992 000
00815871020176 K972992 000
00815871020169 K972992 000
00817770025719 K972992 000
10884521542617 K972992 000
00817770025788 K972992 000
00817770025641 K972992 000
00853061006463 K972992 000
00853061006470 K972992 000
00853061006616 K972992 000
00853061006609 K972992 000
00853061006593 K972992 000
00853061006586 K972992 000
00853061006579 K972992 000
00853061006562 K972992 000
00853061006555 K972992 000
00853061006548 K972992 000
00853061006524 K972992 000
00853061006500 K972992 000
00853061006494 K972992 000
00817770025665 K972992 000
00813841021291 K972992 000
00817770021247 K972992 000
00817770021087 K972992 000
00817770021070 K972992 000
00817770021063 K972992 000
00817770021056 K972992 000
00817770021049 K972992 000
00817770021032 K972992 000
00817770021025 K972992 000
00817770020851 K972992 000
00817770020844 K972992 000
00817770020837 K972992 000
00817770021254 K972992 000
00817770021278 K972992 000
00085306100647 K972992 000
00817770021599 K972992 000
00817770021582 K972992 000
00817770021575 K972992 000
00817770021537 K972992 000
00817770021469 K972992 000
00817770021438 K972992 000
00817770021407 K972992 000
00817770021360 K972992 000
00817770021353 K972992 000
00817770021285 K972992 000
00817770020523 K972992 000
00817770020516 K972992 000
00817770020363 K972992 000
00817770020226 K972992 000
00817770020219 K972992 000
00817770020202 K972992 000
00817770020196 K972992 000
00817770020189 K972992 000
00817770020172 K972992 000
00817770020165 K972992 000
00817770020158 K972992 000
00817770020141 K972992 000
00817770020134 K972992 000
00817770020127 K972992 000
00817770020233 K972992 000
00817770020240 K972992 000
00817770020356 K972992 000
00817770020349 K972992 000
00817770020332 K972992 000
00817770020325 K972992 000
00817770020318 K972992 000
00817770020301 K972992 000
00817770020295 K972992 000
00817770020288 K972992 000
00817770020271 K972992 000
00817770020264 K972992 000
00817770020257 K972992 000
00817770020110 K972992 000

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.