Name: Predicase
Price: 199 USD

K-number	K153448
Device name	Passport Series Patient Monitors (Including Passport 8, Passport 12)
Applicant	Shenzhen Mindray Bio-Medical Electronics Co., Ltd.
Product code	MHX
Device class	Class II
Decision date	Mar 3, 2016
Decision	Substantially Equivalent
Regulation	870.1025

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Source

View the full FDA submission: accessdata.fda.gov

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Passport Series Patient Monitors (Including Passport 8, Passport 12)

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