The following data is part of a premarket notification filed by Fisher & Paykel Electronics Ltd. with the FDA for Mr290 Humidification Chamber Single Use.
| Device ID | K934140 |
| 510k Number | K934140 |
| Device Name: | MR290 HUMIDIFICATION CHAMBER SINGLE USE |
| Classification | Humidifier, Respiratory Gas, (direct Patient Interface) |
| Applicant | FISHER & PAYKEL ELECTRONICS LTD. 25 CARBINE ROAD PANMURE P.O. BOX 14 348 PANMURE Auckland, New Zealand, NZ |
| Contact | Chris Mander |
| Correspondent | Chris Mander FISHER & PAYKEL ELECTRONICS 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 | 1993-08-25 |
| Decision Date | 1994-01-24 |