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FDA 510(k)

ST/AR ST AND ARRHYTHMIA SOFTWARE, MODEL RELEASE D.0

K-Number: K003621 · 2000-12-20

ApplicantAgilent Technologies, Inc.
Decision Date2000-12-20
Product CodeMHX
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

ST/AR ST AND ARRHYTHMIA SOFTWARE, MODEL RELEASE D.0 is the device name listed in this FDA 510(k) record. The listed applicant is Agilent Technologies, Inc.. It received FDA 510(k) clearance on 2000-12-20 under 510(k) number K003621. The device is classified under product code MHX. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ST/AR ST AND ARRHYTHMIA SOFTWARE, MODEL RELEASE D.0?

ST/AR ST AND ARRHYTHMIA SOFTWARE, MODEL RELEASE D.0 is a medical device that received FDA 510(k) clearance on 2000-12-20. The listed applicant is Agilent Technologies, Inc.. The 510(k) number is K003621.

When did ST/AR ST AND ARRHYTHMIA SOFTWARE, MODEL RELEASE D.0 receive FDA 510(k) clearance?

ST/AR ST AND ARRHYTHMIA SOFTWARE, MODEL RELEASE D.0 received FDA 510(k) clearance on 2000-12-20, under 510(k) number K003621.

Who is the listed applicant for ST/AR ST AND ARRHYTHMIA SOFTWARE, MODEL RELEASE D.0?

The FDA 510(k) record lists Agilent Technologies, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for ST/AR ST AND ARRHYTHMIA SOFTWARE, MODEL RELEASE D.0?

The FDA product code for ST/AR ST AND ARRHYTHMIA SOFTWARE, MODEL RELEASE D.0 is MHX.

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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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