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FDA 510(k)

KOO SMALL VOLUME NEBULIZER (SVN)

K-Number: K112041 · 2011-12-22

ApplicantKoo (Shanghai) Industries Co., Ltd.
Decision Date2011-12-22
Product CodeCAF
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

KOO SMALL VOLUME NEBULIZER (SVN) is the device name listed in this FDA 510(k) record. The listed applicant is Koo (Shanghai) Industries Co., Ltd.. It received FDA 510(k) clearance on 2011-12-22 under 510(k) number K112041. 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 KOO SMALL VOLUME NEBULIZER (SVN)?

KOO SMALL VOLUME NEBULIZER (SVN) is a medical device that received FDA 510(k) clearance on 2011-12-22. The listed applicant is Koo (Shanghai) Industries Co., Ltd.. The 510(k) number is K112041.

When did KOO SMALL VOLUME NEBULIZER (SVN) receive FDA 510(k) clearance?

KOO SMALL VOLUME NEBULIZER (SVN) received FDA 510(k) clearance on 2011-12-22, under 510(k) number K112041.

Who is the listed applicant for KOO SMALL VOLUME NEBULIZER (SVN)?

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

What is the FDA product code for KOO SMALL VOLUME NEBULIZER (SVN)?

The FDA product code for KOO SMALL VOLUME NEBULIZER (SVN) is CAF.

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Other records listing Koo (Shanghai) Industries Co., Ltd. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K101136FISIO CHAMBER SPACE

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Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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Official Source

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