FDA 510(k)

FLOW-i Anesthesia System C20, FLOW-i Anesthesia System C30, FLOW-i Anesthesia System C40

Número K: K160665 · 2017-03-29

Data da decisão2017-03-29

Código do produtoBSZ

Comité consultivoAN

DecisãoSubstantially Equivalent

Resumo do dispositivo

FLOW-i Anesthesia System C20, FLOW-i Anesthesia System C30, FLOW-i Anesthesia System C40 is the device name listed in this FDA 510(k) record. The listed applicant is Maquet Critical Care AB. It received FDA 510(k) clearance on 2017-03-29 under 510(k) number K160665. The device is classified under product code BSZ. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the FLOW-i Anesthesia System C20, FLOW-i Anesthesia System C30, FLOW-i Anesthesia System C40?

FLOW-i Anesthesia System C20, FLOW-i Anesthesia System C30, FLOW-i Anesthesia System C40 is a medical device that received FDA 510(k) clearance on 2017-03-29. The listed applicant is Maquet Critical Care AB. The 510(k) number is K160665.

When did FLOW-i Anesthesia System C20, FLOW-i Anesthesia System C30, FLOW-i Anesthesia System C40 receive FDA 510(k) clearance?

FLOW-i Anesthesia System C20, FLOW-i Anesthesia System C30, FLOW-i Anesthesia System C40 received FDA 510(k) clearance on 2017-03-29, under 510(k) number K160665.

Who is the listed applicant for FLOW-i Anesthesia System C20, FLOW-i Anesthesia System C30, FLOW-i Anesthesia System C40?

The FDA 510(k) record lists Maquet Critical Care AB as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for FLOW-i Anesthesia System C20, FLOW-i Anesthesia System C30, FLOW-i Anesthesia System C40?

The FDA product code for FLOW-i Anesthesia System C20, FLOW-i Anesthesia System C30, FLOW-i Anesthesia System C40 is BSZ.

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Outros registros que listam Maquet Critical Care AB como candidato(a)

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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.K201957Sistema de Anestesia A8, A9Shenzhen Mindray Bio-Medical Electronics Co., Ltd.

Fonte oficial

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