FDA 510(k)

BIOZ.PC HEMODYNAMIC MONITOR MODEL BZ-500/BZ-501; BIOZ.PC USER SOFTWARE INSTALLATION KIT MODEL BZ-810

K-Number: K001081 · 2000-06-30

ApplicantCardiodynamics International Corp.

Decision Date2000-06-30

Product CodeDSB

Advisory CommitteeCV

DecisionSubstantially Equivalent

Device Summary

BIOZ.PC HEMODYNAMIC MONITOR MODEL BZ-500/BZ-501; BIOZ.PC USER SOFTWARE INSTALLATION KIT MODEL BZ-810 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 2000-06-30 under 510(k) number K001081. 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.PC HEMODYNAMIC MONITOR MODEL BZ-500/BZ-501; BIOZ.PC USER SOFTWARE INSTALLATION KIT MODEL BZ-810?

BIOZ.PC HEMODYNAMIC MONITOR MODEL BZ-500/BZ-501; BIOZ.PC USER SOFTWARE INSTALLATION KIT MODEL BZ-810 is a medical device that received FDA 510(k) clearance on 2000-06-30. The listed applicant is Cardiodynamics International Corp.. The 510(k) number is K001081.

When did BIOZ.PC HEMODYNAMIC MONITOR MODEL BZ-500/BZ-501; BIOZ.PC USER SOFTWARE INSTALLATION KIT MODEL BZ-810 receive FDA 510(k) clearance?

BIOZ.PC HEMODYNAMIC MONITOR MODEL BZ-500/BZ-501; BIOZ.PC USER SOFTWARE INSTALLATION KIT MODEL BZ-810 received FDA 510(k) clearance on 2000-06-30, under 510(k) number K001081.

Who is the listed applicant for BIOZ.PC HEMODYNAMIC MONITOR MODEL BZ-500/BZ-501; BIOZ.PC USER SOFTWARE INSTALLATION KIT MODEL BZ-810?

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.PC HEMODYNAMIC MONITOR MODEL BZ-500/BZ-501; BIOZ.PC USER SOFTWARE INSTALLATION KIT MODEL BZ-810?

The FDA product code for BIOZ.PC HEMODYNAMIC MONITOR MODEL BZ-500/BZ-501; BIOZ.PC USER SOFTWARE INSTALLATION KIT MODEL BZ-810 is 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.