FDA 510(k)

LEVITRONIX 2ND GENERATION CENTRIMAG PRIMARY CONSOLE, LEVITRONIX MONITOR

K-Number: K102129 · 2010-08-27

Decision Date2010-08-27

Product CodeDWA

Advisory CommitteeCV

DecisionSubstantially Equivalent

Device Summary

LEVITRONIX 2ND GENERATION CENTRIMAG PRIMARY CONSOLE, LEVITRONIX MONITOR is the device name listed in this FDA 510(k) record. The listed applicant is Levitronix, LLC. It received FDA 510(k) clearance on 2010-08-27 under 510(k) number K102129. 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 2ND GENERATION CENTRIMAG PRIMARY CONSOLE, LEVITRONIX MONITOR?

LEVITRONIX 2ND GENERATION CENTRIMAG PRIMARY CONSOLE, LEVITRONIX MONITOR is a medical device that received FDA 510(k) clearance on 2010-08-27. The listed applicant is Levitronix, LLC. The 510(k) number is K102129.

When did LEVITRONIX 2ND GENERATION CENTRIMAG PRIMARY CONSOLE, LEVITRONIX MONITOR receive FDA 510(k) clearance?

LEVITRONIX 2ND GENERATION CENTRIMAG PRIMARY CONSOLE, LEVITRONIX MONITOR received FDA 510(k) clearance on 2010-08-27, under 510(k) number K102129.

Who is the listed applicant for LEVITRONIX 2ND GENERATION CENTRIMAG PRIMARY CONSOLE, LEVITRONIX MONITOR?

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 2ND GENERATION CENTRIMAG PRIMARY CONSOLE, LEVITRONIX MONITOR?

The FDA product code for LEVITRONIX 2ND GENERATION CENTRIMAG PRIMARY CONSOLE, LEVITRONIX MONITOR is 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.