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FDA 510(k)

CARDIO-VIEW

K-Number: K083321 · 2008-11-26

ApplicantCurlview Igt, LLC
Decision Date2008-11-26
Product CodeDXJ
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

CARDIO-VIEW is the device name listed in this FDA 510(k) record. The listed applicant is Curlview Igt, LLC. It received FDA 510(k) clearance on 2008-11-26 under 510(k) number K083321. The device is classified under product code DXJ. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the CARDIO-VIEW?

CARDIO-VIEW is a medical device that received FDA 510(k) clearance on 2008-11-26. The listed applicant is Curlview Igt, LLC. The 510(k) number is K083321.

When did CARDIO-VIEW receive FDA 510(k) clearance?

CARDIO-VIEW received FDA 510(k) clearance on 2008-11-26, under 510(k) number K083321.

Who is the listed applicant for CARDIO-VIEW?

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

What is the FDA product code for CARDIO-VIEW?

The FDA product code for CARDIO-VIEW is DXJ.

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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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