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FDA 510(k)

QUIXIE NEBULIZER

K-Number: K112564 · 2011-11-23

ApplicantOdyssey Medical Technologies
Decision Date2011-11-23
Product CodeCAF
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

QUIXIE NEBULIZER is the device name listed in this FDA 510(k) record. The listed applicant is Odyssey Medical Technologies. It received FDA 510(k) clearance on 2011-11-23 under 510(k) number K112564. The device is classified under product code CAF. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the QUIXIE NEBULIZER?

QUIXIE NEBULIZER is a medical device that received FDA 510(k) clearance on 2011-11-23. The listed applicant is Odyssey Medical Technologies. The 510(k) number is K112564.

When did QUIXIE NEBULIZER receive FDA 510(k) clearance?

QUIXIE NEBULIZER received FDA 510(k) clearance on 2011-11-23, under 510(k) number K112564.

Who is the listed applicant for QUIXIE NEBULIZER?

The FDA 510(k) record lists Odyssey Medical Technologies as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for QUIXIE NEBULIZER?

The FDA product code for QUIXIE NEBULIZER is CAF.

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Official Source

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