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FDA 510(k)

MODALIXX

K-Number: K110108 · 2011-03-16

ApplicantAmpronix, Inc.
Decision Date2011-03-16
Product CodeLLZ
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

MODALIXX is the device name listed in this FDA 510(k) record. The listed applicant is Ampronix, Inc.. It received FDA 510(k) clearance on 2011-03-16 under 510(k) number K110108. 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 MODALIXX?

MODALIXX is a medical device that received FDA 510(k) clearance on 2011-03-16. The listed applicant is Ampronix, Inc.. The 510(k) number is K110108.

When did MODALIXX receive FDA 510(k) clearance?

MODALIXX received FDA 510(k) clearance on 2011-03-16, under 510(k) number K110108.

Who is the listed applicant for MODALIXX?

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

What is the FDA product code for MODALIXX?

The FDA product code for MODALIXX 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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