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FDA 510(k)

ESON NASAL MASK

K-Number: K121597 · 2012-10-02

ApplicantFisher & Paykel Healthcare Limited
Decision Date2012-10-02
Product CodeBZD
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

ESON 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 2012-10-02 under 510(k) number K121597. 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 ESON NASAL MASK?

ESON NASAL MASK is a medical device that received FDA 510(k) clearance on 2012-10-02. The listed applicant is Fisher & Paykel Healthcare Limited. The 510(k) number is K121597.

When did ESON NASAL MASK receive FDA 510(k) clearance?

ESON NASAL MASK received FDA 510(k) clearance on 2012-10-02, under 510(k) number K121597.

Who is the listed applicant for ESON 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 ESON NASAL MASK?

The FDA product code for ESON NASAL MASK is BZD.

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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.

K262268Optiflow Oxygen Kit (AA484J)K243583F&P Nova Nasal MaskK233829Nova Micro Pillows Mask Small A Model (NVP1SA); Nova Micro Pillows Mask Medium A Model (NVP1MA); Nova Micro Pillows Mask Large A Model (NVP1LA); Nova Micro Pillows Mask Fit Pack/SML A Model (NVP1SMLA); Nova Micro Pillows Mask Small Sleep Lab A (NVP1SSLA); Nova Micro Pillows Mask Medium Sleep Lab A (NVP1MSLA); Nova Micro Pillows Mask Large Sleep Lab A (NVP1LSLA); Nova Micro Pillows Mask Fit Pack Sleep Lab A (NVP1SMLSLA)K211560Airvo Nebulizer AdapterK191624F&P Nivairo RT047 Vented Hospital Full Face Mask, Anti-Asphyxiation Valve VersionK173770OJR215 Pressure Relief Manifold

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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.

K261262Altis Full Face MaskRespironics, Inc.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.

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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