The following data is part of a premarket notification filed by Analytical Products, Inc. with the FDA for Dynex Co2/2000, Co2 Analyzer.
| Device ID | K862543 |
| 510k Number | K862543 |
| Device Name: | DYNEX CO2/2000, CO2 ANALYZER |
| Classification | Analyzer, Gas, Carbon-dioxide, Gaseous-phase |
| Applicant | ANALYTICAL PRODUCTS, INC. 511 TAYLOR WAY Belmont , CA 94002 - |
| Contact | Ronald B Smernoff |
| Correspondent | Ronald B Smernoff ANALYTICAL PRODUCTS, INC. 511 TAYLOR WAY Belmont , CA 94002 - |
| Product Code | CCK |
| CFR Regulation Number | 868.1400 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1986-07-03 |
| Decision Date | 1986-07-15 |