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FDA 510(k)

ST/AR ST AND ARRHYTHMIA SOFTWARE

K-Number: K001348 · 2000-05-17

ApplicantAgilent Technologies, Inc.
Decision Date2000-05-17
Product CodeMHX
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

ST/AR ST AND ARRHYTHMIA SOFTWARE 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 2000-05-17 under 510(k) number K001348. 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?

ST/AR ST AND ARRHYTHMIA SOFTWARE is a medical device that received FDA 510(k) clearance on 2000-05-17. The listed applicant is Agilent Technologies, Inc.. The 510(k) number is K001348.

When did ST/AR ST AND ARRHYTHMIA SOFTWARE receive FDA 510(k) clearance?

ST/AR ST AND ARRHYTHMIA SOFTWARE received FDA 510(k) clearance on 2000-05-17, under 510(k) number K001348.

Who is the listed applicant for ST/AR ST AND ARRHYTHMIA SOFTWARE?

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?

The FDA product code for ST/AR ST AND ARRHYTHMIA SOFTWARE 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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