FDA 510(k)

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

K-Number: K001100 · 2000-05-05

ApplicantCardiodynamics International Corp.

Decision Date2000-05-05

Product CodeDSB

Advisory CommitteeCV

DecisionSubstantially Equivalent

Device Summary

BIOZ.COM HEMODYNAMIC MONITOR WITH BIOZ TECT SENSOR AND BIOZ TECT CABLE IMPEDANCE PLETHYSMOGRAPH is the device name listed in this FDA 510(k) record. The listed applicant is Cardiodynamics International Corp.. It received FDA 510(k) clearance on 2000-05-05 under 510(k) number K001100. The device is classified under product code DSB. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the BIOZ.COM HEMODYNAMIC MONITOR WITH BIOZ TECT SENSOR AND BIOZ TECT CABLE IMPEDANCE PLETHYSMOGRAPH?

BIOZ.COM HEMODYNAMIC MONITOR WITH BIOZ TECT SENSOR AND BIOZ TECT CABLE IMPEDANCE PLETHYSMOGRAPH is a medical device that received FDA 510(k) clearance on 2000-05-05. The listed applicant is Cardiodynamics International Corp.. The 510(k) number is K001100.

When did BIOZ.COM HEMODYNAMIC MONITOR WITH BIOZ TECT SENSOR AND BIOZ TECT CABLE IMPEDANCE PLETHYSMOGRAPH receive FDA 510(k) clearance?

BIOZ.COM HEMODYNAMIC MONITOR WITH BIOZ TECT SENSOR AND BIOZ TECT CABLE IMPEDANCE PLETHYSMOGRAPH received FDA 510(k) clearance on 2000-05-05, under 510(k) number K001100.

Who is the listed applicant for BIOZ.COM HEMODYNAMIC MONITOR WITH BIOZ TECT SENSOR AND BIOZ TECT CABLE IMPEDANCE PLETHYSMOGRAPH?

The FDA 510(k) record lists Cardiodynamics International Corp. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for BIOZ.COM HEMODYNAMIC MONITOR WITH BIOZ TECT SENSOR AND BIOZ TECT CABLE IMPEDANCE PLETHYSMOGRAPH?

The FDA product code for BIOZ.COM HEMODYNAMIC MONITOR WITH BIOZ TECT SENSOR AND BIOZ TECT CABLE IMPEDANCE PLETHYSMOGRAPH is DSB.

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Other records listing Cardiodynamics International Corp. as applicant

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Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.