SV600, SV800 Ventilator
K-Number: K243767 · 2025-08-28
Device Summary
Frequently Asked Questions
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.
Other records listing Shenzhen Mindray Bio-Medical Electronics 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.
Related Devices (Code: CBK)
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.
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.