Name: Predicase
Price: 199 USD

K-number	K073593
Device name	I2S DOPPLER PROBE ( 6 HOUR), I2S DOPPLER PROBE (24 HOUR), I2C DOPPLER PROBE (72 HOUR), MODELS 9090-7015, 9090-7016
Applicant	Deltex Medical Limited
Product code	DPT
Device class	Class II
Decision date	Jan 29, 2009
Decision	Substantially Equivalent
Regulation	870.2120

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Source

View the full FDA submission: accessdata.fda.gov

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I2S DOPPLER PROBE ( 6 HOUR), I2S DOPPLER PROBE (24 HOUR), I2C DOPPLER PROBE (72 HOUR), MODELS 9090-7015, 9090-7016

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