K033710 is an FDA 510(k) clearance for the MR850 RESPIRATORY HUMIDIFIER, MODEL MR850JHU. This device is classified as a Humidifier, Respiratory Gas, (direct Patient Interface) (Class II - Special Controls, product code BTT).
Submitted by Fisher &Paykel Healthcare , Ltd. (Panmure, Auckland, NZ). The FDA issued a Cleared decision on April 13, 2004, 139 days after receiving the submission on November 26, 2003.
This device falls under the Anesthesiology FDA review panel. Regulated under 21 CFR 868.5450.
| 510(k) Number | K033710 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | November 26, 2003 |
| Decision Date | April 13, 2004 |
| Days to Decision | 139 days |
| Submission Type | Traditional |
| Review Panel | Anesthesiology (AN) |
| Summary | Summary PDF |
| Product Code | BTT — Humidifier, Respiratory Gas, (direct Patient Interface) |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 868.5450 |