FDA 510(k)

Sistema de Anestesia A8, A9

N.º K: K201957 · 2021-03-26

SolicitanteShenzhen Mindray Bio-Medical Electronics Co., Ltd.

Fecha de decisión2021-03-26

Código de productoBSZ

Comité asesorAN

DecisiónSubstantially Equivalent

Resumen del dispositivo

A8, A9 Anesthesia System is the device name listed in this FDA 510(k) record. The listed applicant is Shenzhen Mindray Bio-Medical Electronics Co., Ltd.. It received FDA 510(k) clearance on 2021-03-26 under 510(k) number K201957. The device is classified under product code BSZ. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

Preguntas frecuentes

What is the A8, A9 Anesthesia System?

A8, A9 Anesthesia System is a medical device that received FDA 510(k) clearance on 2021-03-26. The listed applicant is Shenzhen Mindray Bio-Medical Electronics Co., Ltd.. The 510(k) number is K201957.

When did A8, A9 Anesthesia System receive FDA 510(k) clearance?

A8, A9 Anesthesia System received FDA 510(k) clearance on 2021-03-26, under 510(k) number K201957.

Who is the listed applicant for A8, A9 Anesthesia System?

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

What is the FDA product code for A8, A9 Anesthesia System?

The FDA product code for A8, A9 Anesthesia System is BSZ.

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Otros registros que enlistan a Shenzhen Mindray Bio-Medical Electronics Co., Ltd. como solicitante

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Dispositivos relacionados (Código: BSZ)

K253330Sistema de Anestesia A5 (A5); Sistema de Anestesia A7 (A7)Shenzhen Mindray Bio-Medical Electronics Co., Ltd.K252746Atlan (A100); Atlan (A100 XL); Atlan(A350); Atlan (A350 XL)Drägerwerk AG Co. Kgaa K251352Codonics Safe Labeling System-Point of Care Station (PCS) (SLS-700i and related 610i, 620i, 630i series enabled to retrofit RFID features); Codonics Safe Labeling System-Point of Care Station (PCS) (SLS-1, SLS XXX, Multiple Models Pending Configuration)Codonics.Incorporated K230931AtlanDrägerwerk AG Co. Kgaa K213867Carestation 750/750cDatex-Ohmeda, Inc.K191027Flow-i Anesthesia System, Flow-c Anesthesia System, Flow-e Anesthesia SystemMaquet Critical Care AB

Fuente oficial

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Datos procedentes de la API abierta de la FDA. Para obtener la información más actualizada y autoritativa, consulte siempre el registro oficial.