The following data is part of a premarket notification filed by Marquette Gas Analysis Corp. with the FDA for Multi-gas Analyzer (mga).
Device ID | K893589 |
510k Number | K893589 |
Device Name: | MULTI-GAS ANALYZER (MGA) |
Classification | Analyzer, Gas, Carbon-dioxide, Gaseous-phase |
Applicant | MARQUETTE GAS ANALYSIS CORP. 2383 SCHUETZ RD. St. Louis, MO 63146 |
Contact | Michael Lombardo |
Correspondent | Michael Lombardo 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 | 1989-05-09 |
Decision Date | 1989-07-27 |