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FDA 510(k)

Nebulizer Kit

K-Number: K192971 · 2021-07-08

ApplicantExcellentcare Medical (Huizhou) , Ltd.
Decision Date2021-07-08
Product CodeCAF
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

Nebulizer Kit is the device name listed in this FDA 510(k) record. The listed applicant is Excellentcare Medical (Huizhou) , Ltd.. It received FDA 510(k) clearance on 2021-07-08 under 510(k) number K192971. 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 Nebulizer Kit?

Nebulizer Kit is a medical device that received FDA 510(k) clearance on 2021-07-08. The listed applicant is Excellentcare Medical (Huizhou) , Ltd.. The 510(k) number is K192971.

When did Nebulizer Kit receive FDA 510(k) clearance?

Nebulizer Kit received FDA 510(k) clearance on 2021-07-08, under 510(k) number K192971.

Who is the listed applicant for Nebulizer Kit?

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

What is the FDA product code for Nebulizer Kit?

The FDA product code for Nebulizer Kit is CAF.

Related Devices (Code: CAF)

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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