Name: Predicase
Price: 199 USD

K-number	K991786
Device name	MARS UNITY WORKSTATION WITH HEART RATE VARIABILITY (HRV) OPTION
Applicant	General Electric Medical Systems Information Techn
Product code	DPS
Device class	Class II
Decision date	Nov 18, 1999
Decision	Substantially Equivalent
Regulation	870.2340

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Source

View the full FDA submission: accessdata.fda.gov

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MARS UNITY WORKSTATION WITH HEART RATE VARIABILITY (HRV) OPTION

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