FDA 510(k)

SV600, SV800 Ventilator

Numéro K : K243767 · 2025-08-28

DemandeurShenzhen Mindray Bio-Medical Electronics Co., Ltd.

Date de décision2025-08-28

Code produitCBK

Comité consultatifAN

DécisionSubstantially Equivalent

Résumé du dispositif

SV600, SV800 Ventilator 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 2025-08-28 under 510(k) number K243767. The device is classified under product code CBK. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

Questions fréquentes

What is the SV600, SV800 Ventilator?

SV600, SV800 Ventilator is a medical device that received FDA 510(k) clearance on 2025-08-28. The listed applicant is Shenzhen Mindray Bio-Medical Electronics Co., Ltd.. The 510(k) number is K243767.

When did SV600, SV800 Ventilator receive FDA 510(k) clearance?

SV600, SV800 Ventilator received FDA 510(k) clearance on 2025-08-28, under 510(k) number K243767.

Who is the listed applicant for SV600, SV800 Ventilator?

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 SV600, SV800 Ventilator?

The FDA product code for SV600, SV800 Ventilator is CBK.

Essais cliniques associés

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Source officielle

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