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FDA 510(k)

CARDIOTRODE

K-Number: K840646 · 1984-10-26

ApplicantKholber Corp.
Decision Date1984-10-26
Product CodeDRX
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

CARDIOTRODE is the device name listed in this FDA 510(k) record. The listed applicant is Kholber Corp.. It received FDA 510(k) clearance on 1984-10-26 under 510(k) number K840646. The device is classified under product code DRX. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the CARDIOTRODE?

CARDIOTRODE is a medical device that received FDA 510(k) clearance on 1984-10-26. The listed applicant is Kholber Corp.. The 510(k) number is K840646.

When did CARDIOTRODE receive FDA 510(k) clearance?

CARDIOTRODE received FDA 510(k) clearance on 1984-10-26, under 510(k) number K840646.

Who is the listed applicant for CARDIOTRODE?

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

What is the FDA product code for CARDIOTRODE?

The FDA product code for CARDIOTRODE is DRX.

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Related Devices (Code: DRX)

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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