Name: Predicase
Price: 199 USD

K-number	K221496
Device name	Consona N6, Consona N6 Pro, Consona N6 Super, Consona AR, Consona N6S, Consona AE, Consona AT, Consona N6 Exp Diagnostic Ultrasound System, Consona N6 Elite, Consona N6T Diagnostic Ultrasound System
Applicant	Shenzhen Mindray Bio-Medical Electronics Co., Ltd.
Product code	IYN
Device class	Class II
Decision date	Sep 29, 2022
Decision	Substantially Equivalent
Regulation	892.1550

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Source

View the full FDA submission: accessdata.fda.gov

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Consona N6, Consona N6 Pro, Consona N6 Super, Consona AR, Consona N6S, Consona AE, Consona AT, Consona N6 Exp Diagnostic Ultrasound System, Consona N6 Elite, Consona N6T Diagnostic Ultrasound System

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