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FDA 510(k)

HEARTPRINT

K-Number: K942862 · 1995-01-18

ApplicantMedata, Inc.
Decision Date1995-01-18
Product CodeDSH
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

HEARTPRINT is the device name listed in this FDA 510(k) record. The listed applicant is Medata, Inc.. It received FDA 510(k) clearance on 1995-01-18 under 510(k) number K942862. The device is classified under product code DSH. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the HEARTPRINT?

HEARTPRINT is a medical device that received FDA 510(k) clearance on 1995-01-18. The listed applicant is Medata, Inc.. The 510(k) number is K942862.

When did HEARTPRINT receive FDA 510(k) clearance?

HEARTPRINT received FDA 510(k) clearance on 1995-01-18, under 510(k) number K942862.

Who is the listed applicant for HEARTPRINT?

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

What is the FDA product code for HEARTPRINT?

The FDA product code for HEARTPRINT is DSH.

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Related Devices (Code: DSH)

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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