The following data is part of a premarket notification filed by Fisher & Paykel Allied Products Ltd. with the FDA for Mr338 Servo Heated Delivery Humidifier.
| Device ID | K863377 |
| 510k Number | K863377 |
| Device Name: | MR338 SERVO HEATED DELIVERY HUMIDIFIER |
| Classification | Humidifier, Respiratory Gas, (direct Patient Interface) |
| Applicant | FISHER & PAYKEL ALLIED PRODUCTS LTD. 25 CARBINE ROAD, PANMURE P.O. BOX 14-348, PANMURE Auckland, New Zealand, NZ |
| Contact | David Milburn |
| Correspondent | David Milburn FISHER & PAYKEL ALLIED PRODUCTS 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 | 1986-09-03 |
| Decision Date | 1987-02-20 |