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FDA 510(k)

ALERKAN SPIROMETRY FILTER

K-Number: K111587 · 2011-10-20

ApplicantAlerkan, Ltd.
Decision Date2011-10-20
Product CodeBZG
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

ALERKAN SPIROMETRY FILTER is the device name listed in this FDA 510(k) record. The listed applicant is Alerkan, Ltd.. It received FDA 510(k) clearance on 2011-10-20 under 510(k) number K111587. The device is classified under product code BZG. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ALERKAN SPIROMETRY FILTER?

ALERKAN SPIROMETRY FILTER is a medical device that received FDA 510(k) clearance on 2011-10-20. The listed applicant is Alerkan, Ltd.. The 510(k) number is K111587.

When did ALERKAN SPIROMETRY FILTER receive FDA 510(k) clearance?

ALERKAN SPIROMETRY FILTER received FDA 510(k) clearance on 2011-10-20, under 510(k) number K111587.

Who is the listed applicant for ALERKAN SPIROMETRY FILTER?

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

What is the FDA product code for ALERKAN SPIROMETRY FILTER?

The FDA product code for ALERKAN SPIROMETRY FILTER is BZG.

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Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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