FDA 510(k)

Flow-i Anesthesia System, Flow-c Anesthesia System, Flow-e Anesthesia System

Numéro K : K191027 · 2020-03-18

Date de décision2020-03-18

Code produitBSZ

Comité consultatifAN

DécisionSubstantially Equivalent

Résumé du dispositif

Flow-i Anesthesia System, Flow-c Anesthesia System, Flow-e Anesthesia System 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 2020-03-18 under 510(k) number K191027. The device is classified under product code BSZ. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

Questions fréquentes

What is the Flow-i Anesthesia System, Flow-c Anesthesia System, Flow-e Anesthesia System?

Flow-i Anesthesia System, Flow-c Anesthesia System, Flow-e Anesthesia System is a medical device that received FDA 510(k) clearance on 2020-03-18. The listed applicant is Maquet Critical Care AB. The 510(k) number is K191027.

When did Flow-i Anesthesia System, Flow-c Anesthesia System, Flow-e Anesthesia System receive FDA 510(k) clearance?

Flow-i Anesthesia System, Flow-c Anesthesia System, Flow-e Anesthesia System received FDA 510(k) clearance on 2020-03-18, under 510(k) number K191027.

Who is the listed applicant for Flow-i Anesthesia System, Flow-c Anesthesia System, Flow-e Anesthesia System?

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, Flow-c Anesthesia System, Flow-e Anesthesia System?

The FDA product code for Flow-i Anesthesia System, Flow-c Anesthesia System, Flow-e Anesthesia System is BSZ.

Essais cliniques associés

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Autres dossiers indiquant Maquet Critical Care AB en tant que demandeur

K253715Edi Catheter ENFit 6Fr/48 cm (6893166); Edi Catheter ENFit 6Fr/49cm (6893273); Edi Catheter ENFit 6Fr/50cm (6893274); Edi Catheter ENFit 8Fr/50cm (6893275); Edi Catheter ENFit 8Fr/100cm (6893276); Edi Catheter ENFit 8Fr/125cm (6893277); Edi Catheter ENFit 12Fr/125cm (6893278); Edi Catheter ENFit 16Fr/125cm (6893279)K230173Servo-air Lite Ventilator System K201874Servo-u Ventilator System 4.1, Servo-n Ventilator System 4.1, Servo-u MR Ventilator System 4.1 K182862Servo Guard K180098SERVO-U Ventilator System version 2.1; SERVO-n Ventilator System version 2.1 K160665FLOW-i Anesthesia System C20, FLOW-i Anesthesia System C30, FLOW-i Anesthesia System C40

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Dispositifs connexes (Code : BSZ)

K253330Système d'anesthésie A5 (A5); Système d'anesthésie 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.K201957Système d'anesthésie A8, A9Shenzhen Mindray Bio-Medical Electronics Co., Ltd.

Source officielle

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