The following data is part of a premarket notification filed by Fisher & Paykel Healthcare, Ltd. with the FDA for Airvo 2 Humidifier, Myairvo 2 Humidifier.
| Device ID | K131895 |
| 510k Number | K131895 |
| Device Name: | AIRVO 2 HUMIDIFIER, MYAIRVO 2 HUMIDIFIER |
| Classification | Humidifier, Respiratory Gas, (direct Patient Interface) |
| Applicant | FISHER & PAYKEL HEALTHCARE, LTD. 15 MAURICE PAYKEL PLACE East Tamaki, NZ 2013 |
| Contact | Brett Whiston |
| Correspondent | Brett Whiston FISHER & PAYKEL HEALTHCARE, LTD. 15 MAURICE PAYKEL PLACE East Tamaki, 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 | 2013-06-25 |
| Decision Date | 2013-10-24 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 09420012427830 | K131895 | 000 |
| 09420012467577 | K131895 | 000 |
| 09420012422248 | K131895 | 000 |
| 09420012422347 | K131895 | 000 |
| 09420012422859 | K131895 | 000 |
| 09420012427786 | K131895 | 000 |
| 09420012427823 | K131895 | 000 |
| 09420012427816 | K131895 | 000 |
| 09420012427793 | K131895 | 000 |
| 10190752102484 | K131895 | 000 |