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 |