The following data is part of a premarket notification filed by Hudson Oxygen Therapy Sales Co. with the FDA for Monitor 5590- Analyzer 5595ec.
| Device ID | K840565 |
| 510k Number | K840565 |
| Device Name: | MONITOR 5590- ANALYZER 5595EC |
| Classification | Analyzer, Gas, Oxygen, Gaseous-phase |
| Applicant | HUDSON OXYGEN THERAPY SALES CO. 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 | 1984-02-08 |
| Decision Date | 1984-04-02 |