The following data is part of a premarket notification filed by Fisher & Paykel Healthcare, Ltd. with the FDA for Mr850 Respiratory Humidifier, Model Mr850jhu.
| Device ID | K033710 |
| 510k Number | K033710 |
| Device Name: | MR850 RESPIRATORY HUMIDIFIER, MODEL MR850JHU |
| Classification | Humidifier, Respiratory Gas, (direct Patient Interface) |
| Applicant | FISHER & PAYKEL HEALTHCARE, LTD. P.O BOX 14-348 Panmure, Auckland, NZ 1701 |
| Contact | Brett Whiston |
| Correspondent | Laura Danielson TUV AMERICA, INC. 1775 OLD HIGHWAY 8 New Brighton, MN 55112 -1891 |
| Product Code | BTT |
| CFR Regulation Number | 868.5450 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | Yes |
| Combination Product | No |
| Date Received | 2003-11-26 |
| Decision Date | 2004-04-13 |
| Summary: | summary |