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 |