The following data is part of a premarket notification filed by Marquest Medical Products, Inc. with the FDA for Water Chambers For St 3000 Heated Humidifier.
Device ID | K962223 |
510k Number | K962223 |
Device Name: | WATER CHAMBERS FOR ST 3000 HEATED HUMIDIFIER |
Classification | Humidifier, Respiratory Gas, (direct Patient Interface) |
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 | BTT |
CFR Regulation Number | 868.5450 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1996-06-10 |
Decision Date | 1997-01-14 |
Summary: | summary |