The following data is part of a premarket notification filed by Fisher & Paykel Allied Products Ltd. with the FDA for Heated Respiratory Humidifier Mr428.
| Device ID | K843903 |
| 510k Number | K843903 |
| Device Name: | HEATED RESPIRATORY HUMIDIFIER MR428 |
| Classification | Humidifier, Respiratory Gas, (direct Patient Interface) |
| Applicant | FISHER & PAYKEL ALLIED PRODUCTS LTD. P.O. BOX 14-348 Panmure , New Zealand , NZ |
| Contact | David Milburn |
| Correspondent | David Milburn FISHER & PAYKEL ALLIED PRODUCTS LTD. P.O. BOX 14-348 Panmure , 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 | 1984-10-03 |
| Decision Date | 1984-10-22 |