FDA 510(k)

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

K-Nummer: K152944 · 2016-01-06

Entscheidungsdatum2016-01-06

ProduktcodeDPS

BeratungsausschussCV

EntscheidungSubstantially Equivalent

Produktübersicht

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.

Häufig gestellte Fragen

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.

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