The following data is part of a premarket notification filed by Novametrix Medical Systems, Inc. with the FDA for Novox Oxygen Analyzer 400.
| Device ID | K840392 |
| 510k Number | K840392 |
| Device Name: | NOVOX OXYGEN ANALYZER 400 |
| Classification | Analyzer, Gas, Oxygen, Gaseous-phase |
| Applicant | NOVAMETRIX MEDICAL SYSTEMS, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | CCL |
| CFR Regulation Number | 868.1720 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1984-01-30 |
| Decision Date | 1984-02-27 |