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FDA 510(k)

ST/AR ST AND ARRHYTHMIA SOFTWARE, RELEASE E.I.

K-Number: K021251 · 2002-05-07

ApplicantPhilips Medical Systems
Decision Date2002-05-07
Product CodeDSI
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

ST/AR ST AND ARRHYTHMIA SOFTWARE, RELEASE E.I. is the device name listed in this FDA 510(k) record. The listed applicant is Philips Medical Systems. It received FDA 510(k) clearance on 2002-05-07 under 510(k) number K021251. The device is classified under product code DSI. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ST/AR ST AND ARRHYTHMIA SOFTWARE, RELEASE E.I.?

ST/AR ST AND ARRHYTHMIA SOFTWARE, RELEASE E.I. is a medical device that received FDA 510(k) clearance on 2002-05-07. The listed applicant is Philips Medical Systems. The 510(k) number is K021251.

When did ST/AR ST AND ARRHYTHMIA SOFTWARE, RELEASE E.I. receive FDA 510(k) clearance?

ST/AR ST AND ARRHYTHMIA SOFTWARE, RELEASE E.I. received FDA 510(k) clearance on 2002-05-07, under 510(k) number K021251.

Who is the listed applicant for ST/AR ST AND ARRHYTHMIA SOFTWARE, RELEASE E.I.?

The FDA 510(k) record lists Philips Medical Systems 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, RELEASE E.I.?

The FDA product code for ST/AR ST AND ARRHYTHMIA SOFTWARE, RELEASE E.I. is DSI.

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Related Devices (Code: DSI)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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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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