Name: Predicase
Price: 199 USD

K-number	K160442
Device name	Lucid M1 Transcranial Doppler Ultrasound System (Lucid M1 System) with 2MHz Transducers
Applicant	Neural Analytics, Inc.
Product code	IYN
Device class	Class II
Decision date	Oct 21, 2016
Decision	Substantially Equivalent
Regulation	892.1550

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Source

View the full FDA submission: accessdata.fda.gov

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Lucid M1 Transcranial Doppler Ultrasound System (Lucid M1 System) with 2MHz Transducers

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