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FDA 510(k)

LEVITRONIX CENTRIMAG PRIMARY CONSOLE, THORATEC CENTRIMAG PRIMARY CONSOLE

K-Number: K081221 · 2008-06-19

ApplicantLevitronix, LLC
Decision Date2008-06-19
Product CodeDWA
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

LEVITRONIX CENTRIMAG PRIMARY CONSOLE, THORATEC CENTRIMAG PRIMARY CONSOLE is the device name listed in this FDA 510(k) record. The listed applicant is Levitronix, LLC. It received FDA 510(k) clearance on 2008-06-19 under 510(k) number K081221. The device is classified under product code DWA. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the LEVITRONIX CENTRIMAG PRIMARY CONSOLE, THORATEC CENTRIMAG PRIMARY CONSOLE?

LEVITRONIX CENTRIMAG PRIMARY CONSOLE, THORATEC CENTRIMAG PRIMARY CONSOLE is a medical device that received FDA 510(k) clearance on 2008-06-19. The listed applicant is Levitronix, LLC. The 510(k) number is K081221.

When did LEVITRONIX CENTRIMAG PRIMARY CONSOLE, THORATEC CENTRIMAG PRIMARY CONSOLE receive FDA 510(k) clearance?

LEVITRONIX CENTRIMAG PRIMARY CONSOLE, THORATEC CENTRIMAG PRIMARY CONSOLE received FDA 510(k) clearance on 2008-06-19, under 510(k) number K081221.

Who is the listed applicant for LEVITRONIX CENTRIMAG PRIMARY CONSOLE, THORATEC CENTRIMAG PRIMARY CONSOLE?

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

What is the FDA product code for LEVITRONIX CENTRIMAG PRIMARY CONSOLE, THORATEC CENTRIMAG PRIMARY CONSOLE?

The FDA product code for LEVITRONIX CENTRIMAG PRIMARY CONSOLE, THORATEC CENTRIMAG PRIMARY CONSOLE is DWA.

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Related Devices (Code: DWA)

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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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