The following data is part of a premarket notification filed by Ceramatec, Inc. with the FDA for Cerion Oxy Threshold Alarm.
| Device ID | K880448 |
| 510k Number | K880448 |
| Device Name: | CERION OXY THRESHOLD ALARM |
| Classification | Analyzer, Gas, Oxygen, Gaseous-phase |
| Applicant | CERAMATEC, INC. 2425 SOUTH 900 WEST Salt Lake City, UT 84119 |
| Contact | Mark Haslam |
| Correspondent | Mark Haslam 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 | 1988-02-02 |
| Decision Date | 1988-03-21 |