The following data is part of a premarket notification filed by Fisher & Paykel Healthcare Ltd. with the FDA for Rt016 Inspiratory Filter.
| Device ID | K133666 |
| 510k Number | K133666 |
| Device Name: | RT016 INSPIRATORY FILTER |
| Classification | Filter, Bacterial, Breathing-circuit |
| Applicant | FISHER & PAYKEL HEALTHCARE LTD. 15 MAURICE PAYKEL PLACE, EAST TAMAKI Auckland, NZ 2013 |
| Contact | Elizabeth Goldstein |
| Correspondent | Elizabeth Goldstein FISHER & PAYKEL HEALTHCARE LTD. 15 MAURICE PAYKEL PLACE, EAST TAMAKI Auckland, NZ 2013 |
| Product Code | CAH |
| CFR Regulation Number | 868.5260 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2013-11-29 |
| Decision Date | 2014-02-05 |
| Summary: | summary |