Name: Predicase
Price: 199 USD

K-number	K120485
Device name	NIHON KOHDEN QP-160 AK TREND PROGRAM WITH THE ADDITION OF DSA ASYMMETRY TREND AND FFT P
Applicant	Nihon Kohden America, Inc.
Product code	OMA
Device class	Class II
Decision date	Mar 16, 2012
Decision	Substantially Equivalent
Regulation	882.1400

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Source

View the full FDA submission: accessdata.fda.gov

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NIHON KOHDEN QP-160 AK TREND PROGRAM WITH THE ADDITION OF DSA ASYMMETRY TREND AND FFT P

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