The following data is part of a premarket notification filed by Fisher & Paykel Healthcare, Ltd. with the FDA for End Expiratory Filter, Model Rt020.
| Device ID | K002839 |
| 510k Number | K002839 |
| Device Name: | END EXPIRATORY FILTER, MODEL RT020 |
| Classification | Filter, Bacterial, Breathing-circuit |
| Applicant | FISHER & PAYKEL HEALTHCARE, LTD. 15 MAURICE PAYKEL PLACE East Tamaki, NZ |
| Contact | Chris Mander |
| Correspondent | Chris Mander FISHER & PAYKEL HEALTHCARE, LTD. 15 MAURICE PAYKEL PLACE East Tamaki, NZ |
| Product Code | CAH |
| CFR Regulation Number | 868.5260 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2000-09-12 |
| Decision Date | 2001-10-04 |