The following data is part of a premarket notification filed by Fisher & Paykel Electronics Ltd. with the FDA for Cpap Humidifier (hc 200).
| Device ID | K973161 |
| 510k Number | K973161 |
| Device Name: | CPAP HUMIDIFIER (HC 200) |
| Classification | Ventilator, Non-continuous (respirator) |
| Applicant | FISHER & PAYKEL ELECTRONICS LTD. HEALTHCARE DIV. 25 CARBINE RD., P.O. BOX 14348 Auckland, NZ |
| Contact | Chris Mander |
| Correspondent | Chris Mander FISHER & PAYKEL ELECTRONICS LTD. HEALTHCARE DIV. 25 CARBINE RD., P.O. BOX 14348 Auckland, NZ |
| Product Code | BZD |
| CFR Regulation Number | 868.5905 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1997-08-22 |
| Decision Date | 1998-07-10 |
| Summary: | summary |