Name: Predicase
Price: 199 USD

K-number	K001100
Device name	BIOZ.COM HEMODYNAMIC MONITOR WITH BIOZ TECT SENSOR AND BIOZ TECT CABLE IMPEDANCE PLETHYSMOGRAPH
Applicant	Cardiodynamics International Corp.
Product code	DSB
Device class	Class II
Decision date	May 5, 2000
Decision	Substantially Equivalent
Regulation	870.2770

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Source

View the full FDA submission: accessdata.fda.gov

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BIOZ.COM HEMODYNAMIC MONITOR WITH BIOZ TECT SENSOR AND BIOZ TECT CABLE IMPEDANCE PLETHYSMOGRAPH

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