BIOZDX HEMODYNAMIC MONITOR AND 12-LEAD ECG

Plethysmograph, Impedance

CARDIODYNAMICS INTERNATIONAL CORP.

The following data is part of a premarket notification filed by Cardiodynamics International Corp. with the FDA for Biozdx Hemodynamic Monitor And 12-lead Ecg.

Pre-market Notification Details

Device IDK051228
510k NumberK051228
Device Name:BIOZDX HEMODYNAMIC MONITOR AND 12-LEAD ECG
ClassificationPlethysmograph, Impedance
Applicant CARDIODYNAMICS INTERNATIONAL CORP. 6175 NANCY RIDGE DR., #300 San Diego,  CA  92121
ContactDennis Hepp
CorrespondentDennis Hepp
CARDIODYNAMICS INTERNATIONAL CORP. 6175 NANCY RIDGE DR., #300 San Diego,  CA  92121
Product CodeDSB  
CFR Regulation Number870.2770 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2005-05-13
Decision Date2005-06-10
Summary:summary

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.