The following data is part of a premarket notification filed by Fisher & Paykel Healthcare, Ltd. with the FDA for Rt019 Inspiratory/expiratory Filter.
| Device ID | K050927 |
| 510k Number | K050927 |
| Device Name: | RT019 INSPIRATORY/EXPIRATORY FILTER |
| Classification | Filter, Bacterial, Breathing-circuit |
| Applicant | FISHER & PAYKEL HEALTHCARE, LTD. 15 MAURICE PAYKEL PLACE P.O. BOX 14-348, PANMURE East Tamaki, Auckland, NZ |
| Contact | Reneta Money |
| Correspondent | Reneta Money FISHER & PAYKEL HEALTHCARE, LTD. 15 MAURICE PAYKEL PLACE P.O. BOX 14-348, PANMURE East Tamaki, Auckland, NZ |
| Product Code | CAH |
| CFR Regulation Number | 868.5260 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2005-04-13 |
| Decision Date | 2005-08-01 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 09420012416452 | K050927 | 000 |