The following data is part of a premarket notification filed by Ceramatec, Inc. with the FDA for Ceramatec Maxcell And Cag Galvanic Oxygen Sensors.
Device ID | K972992 |
510k Number | K972992 |
Device Name: | CERAMATEC MAXCELL AND CAG GALVANIC OXYGEN SENSORS |
Classification | Analyzer, Gas, Oxygen, Gaseous-phase |
Applicant | CERAMATEC, INC. 2425 SOUTH 900 WEST Salt Lake City, UT 84119 |
Contact | Gordon Roth |
Correspondent | Gordon Roth CERAMATEC, INC. 2425 SOUTH 900 WEST Salt Lake City, UT 84119 |
Product Code | CCL |
CFR Regulation Number | 868.1720 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1997-08-12 |
Decision Date | 1998-03-30 |
Summary: | summary |