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FDA 510(k)

ATLANTEAN TRIGGER NEBULIZER

K-Number: K102719 · 2011-07-01

ApplicantAtlantean Corporation
Decision Date2011-07-01
Product CodeCAF
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

ATLANTEAN TRIGGER NEBULIZER is the device name listed in this FDA 510(k) record. The listed applicant is Atlantean Corporation. It received FDA 510(k) clearance on 2011-07-01 under 510(k) number K102719. 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 ATLANTEAN TRIGGER NEBULIZER?

ATLANTEAN TRIGGER NEBULIZER is a medical device that received FDA 510(k) clearance on 2011-07-01. The listed applicant is Atlantean Corporation. The 510(k) number is K102719.

When did ATLANTEAN TRIGGER NEBULIZER receive FDA 510(k) clearance?

ATLANTEAN TRIGGER NEBULIZER received FDA 510(k) clearance on 2011-07-01, under 510(k) number K102719.

Who is the listed applicant for ATLANTEAN TRIGGER NEBULIZER?

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

What is the FDA product code for ATLANTEAN TRIGGER NEBULIZER?

The FDA product code for ATLANTEAN TRIGGER NEBULIZER is CAF.

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Official Source

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