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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 the device name listed in this FDA 510(k) record. The listed applicant is Mortara Instrument, Inc.. It received FDA 510(k) clearance on 2016-01-06 under 510(k) 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. The listed applicant is Mortara Instrument, Inc.. The 510(k) number is K152944.

When did Xscribe Stress Exercise Testing Systems, Q-Stress Stress Exercise Testing Systems receive FDA 510(k) clearance?

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

Who is the listed applicant for Xscribe Stress Exercise Testing Systems, Q-Stress Stress Exercise Testing Systems?

The FDA 510(k) record lists Mortara Instrument, Inc. as the applicant. This does not by itself establish the device manufacturer.

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.

Related Clinical Trials

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Other records listing Mortara Instrument, Inc. as applicant

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Related Devices (Code: DPS)

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.

K252463SE-1202 Series Electrocardiograph (Model: SE-1202, SE-1202E)Edan Instruments, Inc.K251670MAC 7 Resting ECG Analysis SystemGe Medical Systems Information Technologies, Inc.K252361AccurECG Analysis System (v2.0)Accurkardia, Inc.K252474Withings BeamO (SCT02)WithingsK250569Cardiologs Holter PlatformPhilips France CommercialK243252ZBPro DiagnosticZbeats, Inc.

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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