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FDA 510(k)

F&P Brevida™ Nasal Pillows Mask

K-Number: K161412 · 2017-01-18

Decision Date2017-01-18
Product CodeBZD
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

F&P Brevida™ Nasal Pillows Mask is a medical device manufactured by Fisher & Paykel Healthcare, Ltd.. It received FDA 510(k) clearance on 2017-01-18 under approval number K161412. The device is classified under product code BZD. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the F&P Brevida™ Nasal Pillows Mask?

F&P Brevida™ Nasal Pillows Mask is a medical device that received FDA 510(k) clearance on 2017-01-18. It is manufactured by Fisher & Paykel Healthcare, Ltd.. The 510(k) number is K161412.

When was F&P Brevida™ Nasal Pillows Mask approved by the FDA?

F&P Brevida™ Nasal Pillows Mask received FDA 510(k) clearance on 2017-01-18, under approval number K161412.

What company makes F&P Brevida™ Nasal Pillows Mask?

F&P Brevida™ Nasal Pillows Mask is manufactured by Fisher & Paykel Healthcare, Ltd..

What is the FDA product code for F&P Brevida™ Nasal Pillows Mask?

The FDA product code for F&P Brevida™ Nasal Pillows Mask is BZD.

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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.