BIOZ.COM HEMODYNAMIC MONITOR WITH BIOZ TECT SENSOR AND BIOZ TECT CABLE IMPEDANCE PLETHYSMOGRAPH— 510(k) K001100

Name: FDA 510(k) clearance K001100
Creator: U.S. Food and Drug Administration
Published: 2000-05-05

Substantially Equivalent

Cardiodynamics International Corp.

FDA 510(k) clearance K001100 for BIOZ.COM HEMODYNAMIC MONITOR WITH BIOZ TECT SENSOR AND BIOZ TECT CABLE IMPEDANCE PLETHYSMOGRAPH, Substantially Equivalent on 2000-05-05. Applicant: Cardiodynamics International Corp.. Device class: 2.

Clearance details

Applicant: Cardiodynamics International Corp.
Product code: Code DSB
Device class: Class 2
Regulation: 21 CFR 870.2770
Advisory panel: Cardiovascular
Date received: 2000-04-05
Decision date: 2000-05-05
Decision: Substantially Equivalent
Clearance type: Special
Location: San Diego, CA, US

Download summary PDF View on FDA.gov ↗

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