The following data is part of a premarket notification filed by Ceramatec, Inc. with the FDA for Handi Oxygen Analyzer.
| Device ID | K973282 |
| 510k Number | K973282 |
| Device Name: | HANDI OXYGEN ANALYZER |
| 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 | 1997-09-02 |
| Decision Date | 1998-03-04 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10822383135455 | K973282 | 000 |
| 00817770021339 | K973282 | 000 |
| 00817770021322 | K973282 | 000 |
| 00817770020868 | K973282 | 000 |
| 00817770020707 | K973282 | 000 |
| 00817770020691 | K973282 | 000 |
| 10884521542389 | K973282 | 000 |