FDA 510(k)

F&P NivairoTM RT046 Non-Vented Hospital Full Face Mask, Standard Elbow Version

K-Number: K173060 · 2018-01-25

ApplicantFisher and Paykel Healthcare Limited

Decision Date2018-01-25

Product CodeCBK

Advisory CommitteeAN

DecisionSubstantially Equivalent

Device Summary

F&P NivairoTM RT046 Non-Vented Hospital Full Face Mask, Standard Elbow Version is the device name listed in this FDA 510(k) record. The listed applicant is Fisher and Paykel Healthcare Limited. It received FDA 510(k) clearance on 2018-01-25 under 510(k) number K173060. The device is classified under product code CBK. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the F&P NivairoTM RT046 Non-Vented Hospital Full Face Mask, Standard Elbow Version?

F&P NivairoTM RT046 Non-Vented Hospital Full Face Mask, Standard Elbow Version is a medical device that received FDA 510(k) clearance on 2018-01-25. The listed applicant is Fisher and Paykel Healthcare Limited. The 510(k) number is K173060.

When did F&P NivairoTM RT046 Non-Vented Hospital Full Face Mask, Standard Elbow Version receive FDA 510(k) clearance?

F&P NivairoTM RT046 Non-Vented Hospital Full Face Mask, Standard Elbow Version received FDA 510(k) clearance on 2018-01-25, under 510(k) number K173060.

Who is the listed applicant for F&P NivairoTM RT046 Non-Vented Hospital Full Face Mask, Standard Elbow Version?

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

What is the FDA product code for F&P NivairoTM RT046 Non-Vented Hospital Full Face Mask, Standard Elbow Version?

The FDA product code for F&P NivairoTM RT046 Non-Vented Hospital Full Face Mask, Standard Elbow Version is CBK.

Related Clinical Trials

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Other records listing Fisher and Paykel Healthcare Limited as applicant

Related Devices (Code: CBK)

K253647Evita (V800); Evita (V600)Draegerwerk AG & CO Kgaa K252663Inbentus VersatileIconic Solutions by Murcia, SL K251888VPAP Pediatric Face MaskHsiner Co., Ltd.K232365Vivo 45 LSOconnell Regulatory Consultants, Inc.K252173F&P OptiNIV Hospital Vented Full Face Mask Compatible with Single-limb Circuits – Size A (ONIV117A); F&P OptiNIV Hospital Vented Full Face Mask Compatible with Single-limb Circuits – Size B (ONIV117B); F&P OptiNIV Hospital Vented Full Face Mask Compatible with Single-limb Circuits – Size C (ONIV117C); F&P OptiNIV ONIV117-F Hospital Vented Full Face Mask with optional Expiratory Filter Compatible with Single-limb Circuits - Size A (ONIV117A-F); F&P OptiNIV ONIV117-F Hospital Vented FullFisher & Paykel Healthcare, Ltd.K243767SV600, SV800 VentilatorShenzhen Mindray Bio-Medical Electronics Co., Ltd.

Official Source

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