FDA 510(k)

ARABELLA NCPAP MASKS

K-Number: K030563 · 2003-09-09

Decision Date2003-09-09

Product CodeBZD

Advisory CommitteeAN

DecisionSubstantially Equivalent

Device Summary

ARABELLA NCPAP MASKS is the device name listed in this FDA 510(k) record. The listed applicant is Hamilton Medical AG. It received FDA 510(k) clearance on 2003-09-09 under 510(k) number K030563. 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 ARABELLA NCPAP MASKS?

ARABELLA NCPAP MASKS is a medical device that received FDA 510(k) clearance on 2003-09-09. The listed applicant is Hamilton Medical AG. The 510(k) number is K030563.

When did ARABELLA NCPAP MASKS receive FDA 510(k) clearance?

ARABELLA NCPAP MASKS received FDA 510(k) clearance on 2003-09-09, under 510(k) number K030563.

Who is the listed applicant for ARABELLA NCPAP MASKS?

The FDA 510(k) record lists Hamilton Medical AG as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for ARABELLA NCPAP MASKS?

The FDA product code for ARABELLA NCPAP MASKS is BZD.

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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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Other records listing Hamilton Medical AG as applicant

K201306HAMILTON-C3 K201658Hamilton-C6 K193228Hamilton-G5 K181216HAMILTON-T1, HAMILTON-C1 K163283HAMILTON-H900, HAMILTON-BC8010, HAMILTON-BC4010 K161450HAMILTON-C3

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Related Devices (Code: BZD)

K261262Altis Full Face MaskRespironics, Inc.K253044RXiBreeze PAP System (RXiBreeze 20C)Resvent Medical Technology Co., Ltd.K253553OrionResmed Corp K254104ResScan EssentialsResmed Corp K251920Sleep 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.