The following data is part of a premarket notification filed by Marquest Medical Products, Inc. with the FDA for Heated Wire Circuits For Sct 3000 Heated Humidifier.
| Device ID | K962220 |
| 510k Number | K962220 |
| Device Name: | HEATED WIRE CIRCUITS FOR SCT 3000 HEATED HUMIDIFIER |
| Classification | Heater, Breathing System W/wo Controller (not Humidifier Or Nebulizer |
| 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 | BZE |
| CFR Regulation Number | 868.5270 [🔎] |
| 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 |