The following data is part of a premarket notification filed by Marquest Medical Products, Inc. with the FDA for Marquest Sct 2000, Heated Humidification System.
| Device ID | K880979 |
| 510k Number | K880979 |
| Device Name: | MARQUEST SCT 2000, HEATED HUMIDIFICATION SYSTEM |
| Classification | Humidifier, Respiratory Gas, (direct Patient Interface) |
| Applicant | MARQUEST MEDICAL PRODUCTS, INC. 11039 EAST LANSING CIR. Englewood, CO 80112 |
| Contact | John G Adams |
| Correspondent | John G Adams 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 | 1988-03-08 |
| Decision Date | 1988-07-15 |