Name: Predicase
Price: 199 USD

K-number	K220107
Device name	Mindray SV600 Ventilator, Mindray SV800 Ventilator
Applicant	Shenzhen Mindray Bio-Medical Electronics Co., Ltd.
Product code	CBK
Device class	Class II
Decision date	Jun 16, 2023
Decision	Substantially Equivalent
Regulation	868.5895

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Source

View the full FDA submission: accessdata.fda.gov

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Mindray SV600 Ventilator, Mindray SV800 Ventilator

Everything you need for a 510(k) submission. Nothing you don't.