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FDA 510(k)

Auto CPAP System

K-Number: K211155 · 2022-03-09

ApplicantBMC Medical Co., Ltd.
Decision Date2022-03-09
Product CodeBZD
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

Auto CPAP System is the device name listed in this FDA 510(k) record. The listed applicant is BMC Medical Co., Ltd.. It received FDA 510(k) clearance on 2022-03-09 under 510(k) number K211155. 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 Auto CPAP System?

Auto CPAP System is a medical device that received FDA 510(k) clearance on 2022-03-09. The listed applicant is BMC Medical Co., Ltd.. The 510(k) number is K211155.

When did Auto CPAP System receive FDA 510(k) clearance?

Auto CPAP System received FDA 510(k) clearance on 2022-03-09, under 510(k) number K211155.

Who is the listed applicant for Auto CPAP System?

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

What is the FDA product code for Auto CPAP System?

The FDA product code for Auto CPAP System is BZD.

Other records listing BMC Medical Co., Ltd. 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.

K260171Portable Oxygen Concentrator (PO1 5B, PO1 6B)K253166F6S Full Face Mask (F6S); P6S Nasal Pillows Interface (P6S)K242935Respiration Data Management Software (PAP Link PC)K213169BPAP SystemK163464Viva Nasal Mask (Model: NM4), Numa Full Face Mask (Model: BMC-FM2)

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

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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