The following data is part of a premarket notification filed by Marquest Medical Products, Inc. with the FDA for Sct 3000 Heated Humidifier.
| Device ID | K970478 |
| 510k Number | K970478 |
| Device Name: | SCT 3000 HEATED HUMIDIFIER |
| Classification | Humidifier, Respiratory Gas, (direct Patient Interface) |
| Applicant | MARQUEST MEDICAL PRODUCTS, INC. 11039 EAST LANSING CIR. Englewood, CO 80112 |
| Contact | Thomas W Dielmann |
| Correspondent | Thomas W 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 | 1997-02-07 |
| Decision Date | 1997-07-16 |
| Summary: | summary |