The following data is part of a premarket notification filed by Fisher & Paykel Healthcare, Ltd. with the FDA for Respiratory Humidifier, Model # Mr850.
| Device ID | K983112 |
| 510k Number | K983112 |
| Device Name: | RESPIRATORY HUMIDIFIER, MODEL # MR850 |
| Classification | Humidifier, Respiratory Gas, (direct Patient Interface) |
| Applicant | FISHER & PAYKEL HEALTHCARE, LTD. HEALTHCARE DIV. 25 CARBINE RD. Auckland, NZ |
| Contact | Chris Mander |
| Correspondent | Chris Mander FISHER & PAYKEL HEALTHCARE, LTD. HEALTHCARE DIV. 25 CARBINE RD. Auckland, NZ |
| Product Code | BTT |
| CFR Regulation Number | 868.5450 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1998-09-04 |
| Decision Date | 1998-11-10 |
| Summary: | summary |