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FDA 510(k)

CARDIAC VX

K-Number: K121762 · 2013-01-18

ApplicantGe Medical Systems, LLC
Decision Date2013-01-18
Product CodeLLZ
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

CARDIAC VX is the device name listed in this FDA 510(k) record. The listed applicant is Ge Medical Systems, LLC. It received FDA 510(k) clearance on 2013-01-18 under 510(k) number K121762. The device is classified under product code LLZ. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the CARDIAC VX?

CARDIAC VX is a medical device that received FDA 510(k) clearance on 2013-01-18. The listed applicant is Ge Medical Systems, LLC. The 510(k) number is K121762.

When did CARDIAC VX receive FDA 510(k) clearance?

CARDIAC VX received FDA 510(k) clearance on 2013-01-18, under 510(k) number K121762.

Who is the listed applicant for CARDIAC VX?

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

What is the FDA product code for CARDIAC VX?

The FDA product code for CARDIAC VX is LLZ.

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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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