The following data is part of a premarket notification filed by Marquette Gas Analysis Corp. with the FDA for Mga-ir Sidestream Pco2 Module.
Device ID | K904863 |
510k Number | K904863 |
Device Name: | MGA-IR SIDESTREAM PCO2 MODULE |
Classification | Analyzer, Gas, Carbon-dioxide, Gaseous-phase |
Applicant | MARQUETTE GAS ANALYSIS CORP. 2383 SCHUETZ RD. St. Louis, MO 63146 |
Contact | Joseph M Styer |
Correspondent | Joseph M Styer MARQUETTE GAS ANALYSIS CORP. 2383 SCHUETZ RD. St. Louis, MO 63146 |
Product Code | CCK |
CFR Regulation Number | 868.1400 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1990-10-29 |
Decision Date | 1991-06-19 |