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FDA 510(k)

FIDELITY 200 CARDIAC EVENT RECORDER

K-Number: K071228 · 2007-11-21

ApplicantSignalife, Inc.
Decision Date2007-11-21
Product CodeDXH
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

FIDELITY 200 CARDIAC EVENT RECORDER is the device name listed in this FDA 510(k) record. The listed applicant is Signalife, Inc.. It received FDA 510(k) clearance on 2007-11-21 under 510(k) number K071228. The device is classified under product code DXH. It was reviewed by the CV advisory panel. Product code DXH falls under the category of Hematology, which includes devices for blood cell counting, coagulation testing, and hemoglobin analysis. Devices in this category are subject to specific FDA regulatory requirements. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the FIDELITY 200 CARDIAC EVENT RECORDER?

FIDELITY 200 CARDIAC EVENT RECORDER is a medical device that received FDA 510(k) clearance on 2007-11-21. The listed applicant is Signalife, Inc.. The 510(k) number is K071228.

When did FIDELITY 200 CARDIAC EVENT RECORDER receive FDA 510(k) clearance?

FIDELITY 200 CARDIAC EVENT RECORDER received FDA 510(k) clearance on 2007-11-21, under 510(k) number K071228.

Who is the listed applicant for FIDELITY 200 CARDIAC EVENT RECORDER?

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

What is the FDA product code for FIDELITY 200 CARDIAC EVENT RECORDER?

The FDA product code for FIDELITY 200 CARDIAC EVENT RECORDER is DXH. This falls under the Hematology category.

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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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