The following data is part of a premarket notification filed by Fisher & Paykel Healthcare, Ltd. with the FDA for Respiratory Humidifier, Model Hc150.
| Device ID | K003973 |
| 510k Number | K003973 |
| Device Name: | RESPIRATORY HUMIDIFIER, MODEL HC150 |
| Classification | Humidifier, Respiratory Gas, (direct Patient Interface) |
| 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 | BTT |
| CFR Regulation Number | 868.5450 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2000-12-22 |
| Decision Date | 2001-06-01 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 09420012429148 | K003973 | 000 |
| 09420012413345 | K003973 | 000 |