F&P NivairoTM RT046 Non-Vented Hospital Full Face Mask, Standard Elbow Version— 510(k) K173060
Substantially EquivalentFisher and Paykel Healthcare Limited
FDA 510(k) clearance K173060 for F&P NivairoTM RT046 Non-Vented Hospital Full Face Mask, Standard Elbow Version, Substantially Equivalent on 2018-01-25. Applicant: Fisher and Paykel Healthcare Limited. Device class: 2.
Clearance details
- Applicant
- Fisher and Paykel Healthcare Limited
- Product code
- Code CBK
- Device class
- Class 2
- Regulation
- 21 CFR 868.5895
- Advisory panel
- Anesthesiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Auckland, NZ
Recent devices under product code CBK
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- K170367 — Nivairo RT045 Non-Vented Hospital Full Face Mask Anti-Asphyxiation Valve - Large, Nivairo RT045 Non-Vented Hospital Full Face Mask Anti-Asphyxiation Valve - Medium, Nivairo RT045 Non-Vented Hospital Full Face Mask Anti-Asphyxiation Valve - Small, Nivairo RT045 Non-Vented Hospital Full Face Mask Anti-Asphyxiation Valve - Extra Small
Adverse events under product code CBK
product code CBK- Death
- 736
- Injury
- 3,628
- Malfunction
- 98,786
- Other
- 4
- Total
- 103,154
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Data sourced from openFDA. This site is unofficial and independent of the FDA.