FDA 510(k)

CARDIOMATCH

K-Number: K970970 · 1997-06-13

Decision Date1997-06-13

Product CodeKPS

Advisory CommitteeRA

DecisionSubstantially Equivalent

Device Summary

CARDIOMATCH is the device name listed in this FDA 510(k) record. The listed applicant is Focus Medical SA. It received FDA 510(k) clearance on 1997-06-13 under 510(k) number K970970. The device is classified under product code KPS. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the CARDIOMATCH?

CARDIOMATCH is a medical device that received FDA 510(k) clearance on 1997-06-13. The listed applicant is Focus Medical SA. The 510(k) number is K970970.

When did CARDIOMATCH receive FDA 510(k) clearance?

CARDIOMATCH received FDA 510(k) clearance on 1997-06-13, under 510(k) number K970970.

Who is the listed applicant for CARDIOMATCH?

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

What is the FDA product code for CARDIOMATCH?

The FDA product code for CARDIOMATCH is KPS.

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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.