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FDA 510(k)

CARDIART 108T/313

K-Number: K761014 · 1976-12-06

ApplicantConway Electronic Enterprises , Ltd.
Decision Date1976-12-06
Product CodeDPS
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

CARDIART 108T/313 is the device name listed in this FDA 510(k) record. The listed applicant is Conway Electronic Enterprises , Ltd.. It received FDA 510(k) clearance on 1976-12-06 under 510(k) number K761014. 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 CARDIART 108T/313?

CARDIART 108T/313 is a medical device that received FDA 510(k) clearance on 1976-12-06. The listed applicant is Conway Electronic Enterprises , Ltd.. The 510(k) number is K761014.

When did CARDIART 108T/313 receive FDA 510(k) clearance?

CARDIART 108T/313 received FDA 510(k) clearance on 1976-12-06, under 510(k) number K761014.

Who is the listed applicant for CARDIART 108T/313?

The FDA 510(k) record lists Conway Electronic Enterprises , Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for CARDIART 108T/313?

The FDA product code for CARDIART 108T/313 is DPS.

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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.

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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.

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