The following data is part of a premarket notification filed by Marquest Medical Products, Inc. with the FDA for Disposable Gas Sampling Interface Kits.
Device ID | K960972 |
510k Number | K960972 |
Device Name: | DISPOSABLE GAS SAMPLING INTERFACE KITS |
Classification | Analyzer, Gas, Carbon-dioxide, Gaseous-phase |
Applicant | MARQUEST MEDICAL PRODUCTS, INC. 11039 EAST LANSING CIR. Englewood, CO 80112 |
Contact | Tom Dielmann |
Correspondent | Tom Dielmann MARQUEST MEDICAL PRODUCTS, INC. 11039 EAST LANSING CIR. Englewood, CO 80112 |
Product Code | CCK |
CFR Regulation Number | 868.1400 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1996-03-11 |
Decision Date | 1996-10-18 |
Summary: | summary |