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FDA 510(k)

THE HEART PROTECTOR

K-Number: K944481 · 1995-04-10

ApplicantGaran Scientific, Inc.
Decision Date1995-04-10
Product CodeNXB
Advisory CommitteePM
DecisionSubstantially Equivalent

Device Summary

THE HEART PROTECTOR is the device name listed in this FDA 510(k) record. The listed applicant is Garan Scientific, Inc.. It received FDA 510(k) clearance on 1995-04-10 under 510(k) number K944481. The device is classified under product code NXB. It was reviewed by the PM advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the THE HEART PROTECTOR?

THE HEART PROTECTOR is a medical device that received FDA 510(k) clearance on 1995-04-10. The listed applicant is Garan Scientific, Inc.. The 510(k) number is K944481.

When did THE HEART PROTECTOR receive FDA 510(k) clearance?

THE HEART PROTECTOR received FDA 510(k) clearance on 1995-04-10, under 510(k) number K944481.

Who is the listed applicant for THE HEART PROTECTOR?

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

What is the FDA product code for THE HEART PROTECTOR?

The FDA product code for THE HEART PROTECTOR is NXB.

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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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