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FDA 510(k)

ST80I STRESS TEST SYSTEM

K-Number: K121638 · 2012-07-18

ApplicantPhilips Health Care
Decision Date2012-07-18
Product CodeDQK
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

ST80I STRESS TEST SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Philips Health Care. It received FDA 510(k) clearance on 2012-07-18 under 510(k) number K121638. The device is classified under product code DQK. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ST80I STRESS TEST SYSTEM?

ST80I STRESS TEST SYSTEM is a medical device that received FDA 510(k) clearance on 2012-07-18. The listed applicant is Philips Health Care. The 510(k) number is K121638.

When did ST80I STRESS TEST SYSTEM receive FDA 510(k) clearance?

ST80I STRESS TEST SYSTEM received FDA 510(k) clearance on 2012-07-18, under 510(k) number K121638.

Who is the listed applicant for ST80I STRESS TEST SYSTEM?

The FDA 510(k) record lists Philips Health Care as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for ST80I STRESS TEST SYSTEM?

The FDA product code for ST80I STRESS TEST SYSTEM is DQK.

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Other records listing Philips Health Care as applicant

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Related Devices (Code: DQK)

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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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