The following data is part of a premarket notification filed by Fisher & Paykel Electronics Ltd. with the FDA for Heated Respiratory Humidifier Hc100.
| Device ID | K915460 |
| 510k Number | K915460 |
| Device Name: | HEATED RESPIRATORY HUMIDIFIER HC100 |
| Classification | Humidifier, Respiratory Gas, (direct Patient Interface) |
| Applicant | FISHER & PAYKEL ELECTRONICS LTD. 25 CARBINE ROAD PANMURE P.O. BOX 14 348 PANMURE Auckland, New Zealand, NZ |
| Contact | Richard Belgrave |
| Correspondent | Richard Belgrave FISHER & PAYKEL ELECTRONICS LTD. 25 CARBINE ROAD PANMURE P.O. BOX 14 348 PANMURE Auckland, New Zealand, NZ |
| Product Code | BTT |
| CFR Regulation Number | 868.5450 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1991-12-04 |
| Decision Date | 1993-01-15 |