The following data is part of a premarket notification filed by Davco with the FDA for Misty-ox Prefilled Humidifier, Disp..
| Device ID | K781600 |
| 510k Number | K781600 |
| Device Name: | MISTY-OX PREFILLED HUMIDIFIER, DISP. |
| Classification | Humidifier, Respiratory Gas, (direct Patient Interface) |
| Applicant | DAVCO 15902 Manufacture Lane Huntington Beach, CA 92649 |
| Contact | Richard E Hart |
| Correspondent | Richard E Hart DAVCO 15902 Manufacture Lane Huntington Beach, CA 92649 |
| Product Code | BTT |
| CFR Regulation Number | 868.5450 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1978-09-18 |
| Decision Date | 1978-10-31 |