F&P Nivairo RT047 Vented Hospital Full Face Mask, Anti-Asphyxiation Valve Version
FDA 510(k) clearance K191624 · decided 2020-03-09
Clearance details
- K-number
- K191624
- Device name
- F&P Nivairo RT047 Vented Hospital Full Face Mask, Anti-Asphyxiation Valve Version
- Applicant
- Fisher & Paykel Healthcare Limited
- Decision
- Substantially Equivalent
- Date received
- 2019-06-18
- Decision date
- 2020-03-09
- Days to decision
- 265 days
- Clearance type
- Traditional
- Product code
- MNT
- Device class
- 2
- Regulation number
- 868.5895
- Medical specialty
- Anesthesiology
- Advisory committee
- Anesthesiology
- Location
- Auckland, NZ
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.