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FDA 510(k)

F&P Eson 2 Nasal Mask

K-Number: K153505 · 2016-09-20

ApplicantFisher & Paykel Healthcare Limited
Decision Date2016-09-20
Product CodeBZD
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

F&P Eson 2 Nasal Mask 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 2016-09-20 under 510(k) number K153505. 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 Eson 2 Nasal Mask?

F&P Eson 2 Nasal Mask is a medical device that received FDA 510(k) clearance on 2016-09-20. The listed applicant is Fisher & Paykel Healthcare Limited. The 510(k) number is K153505.

When did F&P Eson 2 Nasal Mask receive FDA 510(k) clearance?

F&P Eson 2 Nasal Mask received FDA 510(k) clearance on 2016-09-20, under 510(k) number K153505.

Who is the listed applicant for F&P Eson 2 Nasal Mask?

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 Eson 2 Nasal Mask?

The FDA product code for F&P Eson 2 Nasal Mask is BZD.

Other records listing Fisher & Paykel Healthcare Limited as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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Related Devices (Code: BZD)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K253044RXiBreeze PAP System (RXiBreeze 20C)Resvent Medical Technology Co., Ltd.K253553OrionResmed CorpK254104ResScan EssentialsResmed CorpK251920Sleep Apnea Breathing Therapy Mask:JoyMask 20-B Full Face Mask, JoyMask 21-B Full Face MaskDcstar, Inc.K253166F6S Full Face Mask (F6S); P6S Nasal Pillows Interface (P6S)BMC Medical Co., Ltd.K252338MySleepDashSomnetics International, Inc. (Dba Transcend Inc)

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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