AIRVO 2 HUMIDIFIER, MYAIRVO 2 HUMIDIFIER
FDA 510(k) clearance K131895 · decided 2013-10-24
Clearance details
- K-number
- K131895
- Device name
- AIRVO 2 HUMIDIFIER, MYAIRVO 2 HUMIDIFIER
- Applicant
- Fisher & Paykel Healthcare, Ltd.
- Decision
- Substantially Equivalent
- Date received
- 2013-06-25
- Decision date
- 2013-10-24
- Days to decision
- 121 days
- Clearance type
- Traditional
- Product code
- BTT
- Device class
- 2
- Regulation number
- 868.5450
- Medical specialty
- Anesthesiology
- Advisory committee
- Anesthesiology
- Location
- Manukau, NZ
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| Airvo 2, REF: PT101US, and myAirvo 2, REF: PT100US, used with Disinfection Kit User Manual recall (Z-0158-2026) | Fisher & Paykel Healthcare, Ltd. | 2025-10-15 |
| Airvo 2 Humidifier, REF: PT101US, and myAirvo 2 Humidifier, REF: PT100US recall (Z-1823-2024) | Fisher & Paykel Healthcare, Ltd. | 2024-05-15 |