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FDA 510(k)

CARDIODYNAMICS BIOZ RX, MODEL 7101-SYS

K-Number: K090602 · 2009-05-28

ApplicantCardiodynamics International Corp.
Decision Date2009-05-28
Product CodeDSB
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

CARDIODYNAMICS BIOZ RX, MODEL 7101-SYS 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 2009-05-28 under 510(k) number K090602. 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 CARDIODYNAMICS BIOZ RX, MODEL 7101-SYS?

CARDIODYNAMICS BIOZ RX, MODEL 7101-SYS is a medical device that received FDA 510(k) clearance on 2009-05-28. The listed applicant is Cardiodynamics International Corp.. The 510(k) number is K090602.

When did CARDIODYNAMICS BIOZ RX, MODEL 7101-SYS receive FDA 510(k) clearance?

CARDIODYNAMICS BIOZ RX, MODEL 7101-SYS received FDA 510(k) clearance on 2009-05-28, under 510(k) number K090602.

Who is the listed applicant for CARDIODYNAMICS BIOZ RX, MODEL 7101-SYS?

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 CARDIODYNAMICS BIOZ RX, MODEL 7101-SYS?

The FDA product code for CARDIODYNAMICS BIOZ RX, MODEL 7101-SYS is DSB.

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Related Devices (Code: DSB)

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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.

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