The following data is part of a premarket notification filed by Martech Medical Products, Inc. with the FDA for Pro2 Oxygen Analyzer.
| Device ID | K922438 |
| 510k Number | K922438 |
| Device Name: | PRO2 OXYGEN ANALYZER |
| Classification | Analyzer, Gas, Oxygen, Gaseous-phase |
| Applicant | MARTECH MEDICAL PRODUCTS, INC. 43223 BUSINESS PARK DR. Temecula, CA 92590 |
| Contact | Steven F Mercereau |
| Correspondent | Steven F Mercereau MARTECH MEDICAL PRODUCTS, INC. 43223 BUSINESS PARK DR. Temecula, CA 92590 |
| Product Code | CCL |
| CFR Regulation Number | 868.1720 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1992-05-22 |
| Decision Date | 1993-03-05 |