The following data is part of a premarket notification filed by Fisher & Paykel Healthcare, Ltd. with the FDA for Airvo Series Humidifiers.
| Device ID | K092846 |
| 510k Number | K092846 |
| Device Name: | AIRVO SERIES HUMIDIFIERS |
| Classification | Humidifier, Respiratory Gas, (direct Patient Interface) |
| Applicant | FISHER & PAYKEL HEALTHCARE, LTD. 15 MAURICE PAYKEL PLACE East Tamaki, Auckland, NZ 2013 |
| Contact | James Thompson |
| Correspondent | James Thompson FISHER & PAYKEL HEALTHCARE, LTD. 15 MAURICE PAYKEL PLACE East Tamaki, Auckland, NZ 2013 |
| Product Code | BTT |
| CFR Regulation Number | 868.5450 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2009-09-15 |
| Decision Date | 2010-01-27 |
| Summary: | summary |