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 |