The following data is part of a premarket notification filed by Fisher & Paykel Electronics Ltd. with the FDA for Models Mr410 & Mr480 Respiratory Humidifier/access.
| Device ID | K913367 |
| 510k Number | K913367 |
| Device Name: | MODELS MR410 & MR480 RESPIRATORY HUMIDIFIER/ACCESS |
| 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 | Richard Belgrave |
| Correspondent | Richard Belgrave 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 | 1991-07-24 |
| Decision Date | 1992-06-25 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 09420012406590 | K913367 | 000 |
| 09420012406576 | K913367 | 000 |
| 09420012406552 | K913367 | 000 |