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FDA 510(k)

PRODIGY AND PRODIGY PLUS

K-Number: K860167 · 1986-03-31

ApplicantCardiodata Corp.
Decision Date1986-03-31
Product CodeDSI
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

PRODIGY AND PRODIGY PLUS is the device name listed in this FDA 510(k) record. The listed applicant is Cardiodata Corp.. It received FDA 510(k) clearance on 1986-03-31 under 510(k) number K860167. 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 PRODIGY AND PRODIGY PLUS?

PRODIGY AND PRODIGY PLUS is a medical device that received FDA 510(k) clearance on 1986-03-31. The listed applicant is Cardiodata Corp.. The 510(k) number is K860167.

When did PRODIGY AND PRODIGY PLUS receive FDA 510(k) clearance?

PRODIGY AND PRODIGY PLUS received FDA 510(k) clearance on 1986-03-31, under 510(k) number K860167.

Who is the listed applicant for PRODIGY AND PRODIGY PLUS?

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

What is the FDA product code for PRODIGY AND PRODIGY PLUS?

The FDA product code for PRODIGY AND PRODIGY PLUS is DSI.

Related Clinical Trials

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Other records listing Cardiodata Corp. as applicant

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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.

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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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