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FDA 510(k)

CARDIOSCAN - TM BEING APPLIED FOR

K-Number: K841263 · 1984-10-19

ApplicantInterspec, Inc.
Decision Date1984-10-19
Product CodeDXK
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

CARDIOSCAN - TM BEING APPLIED FOR is the device name listed in this FDA 510(k) record. The listed applicant is Interspec, Inc.. It received FDA 510(k) clearance on 1984-10-19 under 510(k) number K841263. The device is classified under product code DXK. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the CARDIOSCAN - TM BEING APPLIED FOR?

CARDIOSCAN - TM BEING APPLIED FOR is a medical device that received FDA 510(k) clearance on 1984-10-19. The listed applicant is Interspec, Inc.. The 510(k) number is K841263.

When did CARDIOSCAN - TM BEING APPLIED FOR receive FDA 510(k) clearance?

CARDIOSCAN - TM BEING APPLIED FOR received FDA 510(k) clearance on 1984-10-19, under 510(k) number K841263.

Who is the listed applicant for CARDIOSCAN - TM BEING APPLIED FOR?

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

What is the FDA product code for CARDIOSCAN - TM BEING APPLIED FOR?

The FDA product code for CARDIOSCAN - TM BEING APPLIED FOR is DXK.

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Related Devices (Code: DXK)

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

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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