The following data is part of a premarket notification filed by Analytical Products, Inc. with the FDA for Electrodes For Blood Gas Analyzers.
Device ID | K832981 |
510k Number | K832981 |
Device Name: | ELECTRODES FOR BLOOD GAS ANALYZERS |
Classification | Electrode Measurement, Blood-gases (pco2, Po2) And Blood Ph |
Applicant | ANALYTICAL PRODUCTS, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
Product Code | CHL |
CFR Regulation Number | 862.1120 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1983-09-02 |
Decision Date | 1983-10-28 |