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FDA 510(k)

Xscribe Stress Exercise Testing Systems, Q-Stress Stress Exercise Testing Systems

K-Number: K152944 · 2016-01-06

ApplicantMortara Instrument, Inc.
Decision Date2016-01-06
Product CodeDPS
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

Xscribe Stress Exercise Testing Systems, Q-Stress Stress Exercise Testing Systems is a medical device manufactured by Mortara Instrument, Inc.. It received FDA 510(k) clearance on 2016-01-06 under approval number K152944. The device is classified under product code DPS. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Xscribe Stress Exercise Testing Systems, Q-Stress Stress Exercise Testing Systems?

Xscribe Stress Exercise Testing Systems, Q-Stress Stress Exercise Testing Systems is a medical device that received FDA 510(k) clearance on 2016-01-06. It is manufactured by Mortara Instrument, Inc.. The 510(k) number is K152944.

When was Xscribe Stress Exercise Testing Systems, Q-Stress Stress Exercise Testing Systems approved by the FDA?

Xscribe Stress Exercise Testing Systems, Q-Stress Stress Exercise Testing Systems received FDA 510(k) clearance on 2016-01-06, under approval number K152944.

What company makes Xscribe Stress Exercise Testing Systems, Q-Stress Stress Exercise Testing Systems?

Xscribe Stress Exercise Testing Systems, Q-Stress Stress Exercise Testing Systems is manufactured by Mortara Instrument, Inc..

What is the FDA product code for Xscribe Stress Exercise Testing Systems, Q-Stress Stress Exercise Testing Systems?

The FDA product code for Xscribe Stress Exercise Testing Systems, Q-Stress Stress Exercise Testing Systems is DPS.

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Related PubMed Literature

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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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