The following data is part of a premarket notification filed by Fisher & Paykel Electronics Ltd. with the FDA for Air Entrainer 900rt008.
| Device ID | K953711 |
| 510k Number | K953711 |
| Device Name: | AIR ENTRAINER 900RT008 |
| Classification | Mixer, Breathing Gases, Anesthesia Inhalation |
| 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 | BZR |
| CFR Regulation Number | 868.5330 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1995-08-09 |
| Decision Date | 1995-11-08 |