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FDA 510(k)

F&P Nivairo RT047 Vented Hospital Full Face Mask, Anti-Asphyxiation Valve Version

K-Number: K191624 · 2020-03-09

ApplicantFisher & Paykel Healthcare Limited
Decision Date2020-03-09
Product CodeMNT
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

F&P Nivairo RT047 Vented Hospital Full Face Mask, Anti-Asphyxiation Valve Version is the device name listed in this FDA 510(k) record. The listed applicant is Fisher & Paykel Healthcare Limited. It received FDA 510(k) clearance on 2020-03-09 under 510(k) number K191624. The device is classified under product code MNT. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the F&P Nivairo RT047 Vented Hospital Full Face Mask, Anti-Asphyxiation Valve Version?

F&P Nivairo RT047 Vented Hospital Full Face Mask, Anti-Asphyxiation Valve Version is a medical device that received FDA 510(k) clearance on 2020-03-09. The listed applicant is Fisher & Paykel Healthcare Limited. The 510(k) number is K191624.

When did F&P Nivairo RT047 Vented Hospital Full Face Mask, Anti-Asphyxiation Valve Version receive FDA 510(k) clearance?

F&P Nivairo RT047 Vented Hospital Full Face Mask, Anti-Asphyxiation Valve Version received FDA 510(k) clearance on 2020-03-09, under 510(k) number K191624.

Who is the listed applicant for F&P Nivairo RT047 Vented Hospital Full Face Mask, Anti-Asphyxiation Valve Version?

The FDA 510(k) record lists Fisher & Paykel Healthcare Limited as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for F&P Nivairo RT047 Vented Hospital Full Face Mask, Anti-Asphyxiation Valve Version?

The FDA product code for F&P Nivairo RT047 Vented Hospital Full Face Mask, Anti-Asphyxiation Valve Version is MNT.

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Other records listing Fisher & Paykel Healthcare Limited as applicant

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Related Devices (Code: MNT)

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Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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