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FDA 510(k)

CARDIOTEST EK53/EK53R, CARDIOGNOST EK56/EK512

K-Number: K890875 · 1989-10-17

ApplicantPpg Industries, Inc.
Decision Date1989-10-17
Product CodeDPS
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

CARDIOTEST EK53/EK53R, CARDIOGNOST EK56/EK512 is the device name listed in this FDA 510(k) record. The listed applicant is Ppg Industries, Inc.. It received FDA 510(k) clearance on 1989-10-17 under 510(k) number K890875. 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 CARDIOTEST EK53/EK53R, CARDIOGNOST EK56/EK512?

CARDIOTEST EK53/EK53R, CARDIOGNOST EK56/EK512 is a medical device that received FDA 510(k) clearance on 1989-10-17. The listed applicant is Ppg Industries, Inc.. The 510(k) number is K890875.

When did CARDIOTEST EK53/EK53R, CARDIOGNOST EK56/EK512 receive FDA 510(k) clearance?

CARDIOTEST EK53/EK53R, CARDIOGNOST EK56/EK512 received FDA 510(k) clearance on 1989-10-17, under 510(k) number K890875.

Who is the listed applicant for CARDIOTEST EK53/EK53R, CARDIOGNOST EK56/EK512?

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

What is the FDA product code for CARDIOTEST EK53/EK53R, CARDIOGNOST EK56/EK512?

The FDA product code for CARDIOTEST EK53/EK53R, CARDIOGNOST EK56/EK512 is DPS.

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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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