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FDA 510(k)

PIONEER U121 SERIES CPAP

K-Number: K041823 · 2005-05-10

ApplicantMerits Health Products Co., Ltd.
Decision Date2005-05-10
Product CodeBZD
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

PIONEER U121 SERIES CPAP is the device name listed in this FDA 510(k) record. The listed applicant is Merits Health Products Co., Ltd.. It received FDA 510(k) clearance on 2005-05-10 under 510(k) number K041823. 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 PIONEER U121 SERIES CPAP?

PIONEER U121 SERIES CPAP is a medical device that received FDA 510(k) clearance on 2005-05-10. The listed applicant is Merits Health Products Co., Ltd.. The 510(k) number is K041823.

When did PIONEER U121 SERIES CPAP receive FDA 510(k) clearance?

PIONEER U121 SERIES CPAP received FDA 510(k) clearance on 2005-05-10, under 510(k) number K041823.

Who is the listed applicant for PIONEER U121 SERIES CPAP?

The FDA 510(k) record lists Merits Health Products Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for PIONEER U121 SERIES CPAP?

The FDA product code for PIONEER U121 SERIES CPAP is BZD.

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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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