The following data is part of a premarket notification filed by Fisher & Paykel Healthcare, Ltd. with the FDA for Model Mr2000 Heated Respiratory Humidifier.
| Device ID | K881970 |
| 510k Number | K881970 |
| Device Name: | MODEL MR2000 HEATED RESPIRATORY HUMIDIFIER |
| Classification | Humidifier, Respiratory Gas, (direct Patient Interface) |
| Applicant | FISHER & PAYKEL HEALTHCARE, LTD. 25 CARBINE ROAD PANMURE P.O. BOX 14 348 PANMURE Auckland, New Zealand, NZ |
| Contact | David Milburn |
| Correspondent | David Milburn FISHER & PAYKEL HEALTHCARE, LTD. 25 CARBINE ROAD PANMURE P.O. BOX 14 348 PANMURE Auckland, New Zealand, NZ |
| Product Code | BTT |
| CFR Regulation Number | 868.5450 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1988-05-11 |
| Decision Date | 1989-03-09 |