The following data is part of a premarket notification filed by Fisher & Paykel Electronics Ltd. with the FDA for Humidifier & Accessories.
| Device ID | K953949 |
| 510k Number | K953949 |
| Device Name: | HUMIDIFIER & ACCESSORIES |
| Classification | Generator, Oxygen, Portable |
| Applicant | FISHER & PAYKEL ELECTRONICS LTD. 25 CARBINE ROAD PANMURE P.O. BOX 14 348 PANMURE Auckland, New Zealand, NZ |
| Contact | Adele Yee |
| Correspondent | Adele Yee FISHER & PAYKEL ELECTRONICS LTD. 25 CARBINE ROAD PANMURE P.O. BOX 14 348 PANMURE Auckland, New Zealand, NZ |
| Product Code | CAW |
| CFR Regulation Number | 868.5440 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1995-08-22 |
| Decision Date | 1995-10-16 |