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FDA 510(k)

BPAP System

K-Number: K213169 · 2022-12-05

ApplicantBMC Medical Co., Ltd.
Decision Date2022-12-05
Product CodeMNS
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

BPAP 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 2022-12-05 under 510(k) number K213169. The device is classified under product code MNS. It was reviewed by the AN advisory panel. Product code MNS falls under the category of Neurology, which encompasses devices for neurological diagnosis and monitoring. Devices in this category are subject to specific FDA regulatory requirements. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the BPAP System?

BPAP System is a medical device that received FDA 510(k) clearance on 2022-12-05. The listed applicant is BMC Medical Co., Ltd.. The 510(k) number is K213169.

When did BPAP System receive FDA 510(k) clearance?

BPAP System received FDA 510(k) clearance on 2022-12-05, under 510(k) number K213169.

Who is the listed applicant for BPAP 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 BPAP System?

The FDA product code for BPAP System is MNS. This falls under the Neurology category.

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)K211155Auto CPAP SystemK163464Viva Nasal Mask (Model: NM4), Numa Full Face Mask (Model: BMC-FM2)

Related Devices (Code: MNS)

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.

K251889myAirResmed CorpK252078BreathePal Bilevel (GFM50-MD2201)Compal Electronics, Inc.K251661Mariana Minerva; Mariana NimbusResmed Pty , Ltd.K240778Vivo 1, Vivo 2Breas Medical ABK231064ReddyPort ElbowSmd Manufacturing, LLCK171827ReddyPort NIV Access ElbowSmd Manufacturing, LLC

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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