The following data is part of a premarket notification filed by Rna Medical Corp. with the FDA for Blood Gas Flush Sol. & Flush Agent 1302.
Device ID | K842519 |
510k Number | K842519 |
Device Name: | BLOOD GAS FLUSH SOL. & FLUSH AGENT 1302 |
Classification | Electrode Measurement, Blood-gases (pco2, Po2) And Blood Ph |
Applicant | RNA MEDICAL CORP. 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 | 1984-07-10 |
Decision Date | 1984-08-17 |