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FDA 510(k)

STAR ST AND ARRHYTHMIA SOFTWARE, RELEASE J.0

K-Number: K080461 · 2008-03-13

ApplicantPhilips Medical Systems
Decision Date2008-03-13
Product CodeMLD
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

STAR ST AND ARRHYTHMIA SOFTWARE, RELEASE J.0 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 2008-03-13 under 510(k) number K080461. The device is classified under product code MLD. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the STAR ST AND ARRHYTHMIA SOFTWARE, RELEASE J.0?

STAR ST AND ARRHYTHMIA SOFTWARE, RELEASE J.0 is a medical device that received FDA 510(k) clearance on 2008-03-13. The listed applicant is Philips Medical Systems. The 510(k) number is K080461.

When did STAR ST AND ARRHYTHMIA SOFTWARE, RELEASE J.0 receive FDA 510(k) clearance?

STAR ST AND ARRHYTHMIA SOFTWARE, RELEASE J.0 received FDA 510(k) clearance on 2008-03-13, under 510(k) number K080461.

Who is the listed applicant for STAR ST AND ARRHYTHMIA SOFTWARE, RELEASE J.0?

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 STAR ST AND ARRHYTHMIA SOFTWARE, RELEASE J.0?

The FDA product code for STAR ST AND ARRHYTHMIA SOFTWARE, RELEASE J.0 is MLD.

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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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