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FDA 510(k)

KING OF HEARTS EXPRESS AF CARDIAC EVENT RECORDER

K-Number: K111745 · 2011-08-01

ApplicantCard Guard Scientific Survival , Ltd.
Decision Date2011-08-01
Product CodeDSH
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

KING OF HEARTS EXPRESS AF CARDIAC EVENT RECORDER is the device name listed in this FDA 510(k) record. The listed applicant is Card Guard Scientific Survival , Ltd.. It received FDA 510(k) clearance on 2011-08-01 under 510(k) number K111745. 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 KING OF HEARTS EXPRESS AF CARDIAC EVENT RECORDER?

KING OF HEARTS EXPRESS AF CARDIAC EVENT RECORDER is a medical device that received FDA 510(k) clearance on 2011-08-01. The listed applicant is Card Guard Scientific Survival , Ltd.. The 510(k) number is K111745.

When did KING OF HEARTS EXPRESS AF CARDIAC EVENT RECORDER receive FDA 510(k) clearance?

KING OF HEARTS EXPRESS AF CARDIAC EVENT RECORDER received FDA 510(k) clearance on 2011-08-01, under 510(k) number K111745.

Who is the listed applicant for KING OF HEARTS EXPRESS AF CARDIAC EVENT RECORDER?

The FDA 510(k) record lists Card Guard Scientific Survival , Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for KING OF HEARTS EXPRESS AF CARDIAC EVENT RECORDER?

The FDA product code for KING OF HEARTS EXPRESS AF CARDIAC EVENT RECORDER 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

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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