The following data is part of a premarket notification filed by Fisher & Paykel Healthcare, Ltd. with the FDA for Cpap Humidifier, Model Hc238jhu.
| Device ID | K050904 |
| 510k Number | K050904 |
| Device Name: | CPAP HUMIDIFIER, MODEL HC238JHU |
| Classification | Ventilator, Non-continuous (respirator) |
| Applicant | FISHER & PAYKEL HEALTHCARE, LTD. 15 MAURICE PAYKEL PLACE East Tamaki, NZ |
| Contact | James Thompson |
| Correspondent | James Thompson FISHER & PAYKEL HEALTHCARE, LTD. 15 MAURICE PAYKEL PLACE East Tamaki, NZ |
| Product Code | BZD |
| CFR Regulation Number | 868.5905 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2005-04-11 |
| Decision Date | 2005-05-25 |
| Summary: | summary |