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FDA 510(k)

GRANDCOR/CARDIOLINE ECT STRESS TESTING

K-Number: K895547 · 1990-03-13

Decision Date1990-03-13
Product CodeDSI
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

GRANDCOR/CARDIOLINE ECT STRESS TESTING is the device name listed in this FDA 510(k) record. The listed applicant is Grandcor Medical Systems. It received FDA 510(k) clearance on 1990-03-13 under 510(k) number K895547. The device is classified under product code DSI. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the GRANDCOR/CARDIOLINE ECT STRESS TESTING?

GRANDCOR/CARDIOLINE ECT STRESS TESTING is a medical device that received FDA 510(k) clearance on 1990-03-13. The listed applicant is Grandcor Medical Systems. The 510(k) number is K895547.

When did GRANDCOR/CARDIOLINE ECT STRESS TESTING receive FDA 510(k) clearance?

GRANDCOR/CARDIOLINE ECT STRESS TESTING received FDA 510(k) clearance on 1990-03-13, under 510(k) number K895547.

Who is the listed applicant for GRANDCOR/CARDIOLINE ECT STRESS TESTING?

The FDA 510(k) record lists Grandcor Medical Systems as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for GRANDCOR/CARDIOLINE ECT STRESS TESTING?

The FDA product code for GRANDCOR/CARDIOLINE ECT STRESS TESTING is DSI.

Related Clinical Trials

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.

Other records listing Grandcor Medical Systems as applicant

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.

View all 8 devices →

Related Devices (Code: DSI)

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.

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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