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FDA 510(k)

ST/AR ST AND ARRHYTHMIA SOFTWARE MODEL: RELEASE K.O

K-Number: K101521 · 2010-07-29

ApplicantPhilips Medical Systems
Decision Date2010-07-29
Product CodeMHX
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

ST/AR ST AND ARRHYTHMIA SOFTWARE MODEL: RELEASE K.O 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 2010-07-29 under 510(k) number K101521. 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 K.O?

ST/AR ST AND ARRHYTHMIA SOFTWARE MODEL: RELEASE K.O is a medical device that received FDA 510(k) clearance on 2010-07-29. The listed applicant is Philips Medical Systems. The 510(k) number is K101521.

When did ST/AR ST AND ARRHYTHMIA SOFTWARE MODEL: RELEASE K.O receive FDA 510(k) clearance?

ST/AR ST AND ARRHYTHMIA SOFTWARE MODEL: RELEASE K.O received FDA 510(k) clearance on 2010-07-29, under 510(k) number K101521.

Who is the listed applicant for ST/AR ST AND ARRHYTHMIA SOFTWARE MODEL: RELEASE K.O?

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 MODEL: RELEASE K.O?

The FDA product code for ST/AR ST AND ARRHYTHMIA SOFTWARE MODEL: RELEASE K.O is MHX.

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Other records listing Philips Medical Systems as applicant

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Related Devices (Code: 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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