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FDA 510(k)

ULTRASONIC NEBULIZER

K-Number: K121154 · 2012-08-20

ApplicantFoshan Gaunying Electronics Co., Ltd.
Decision Date2012-08-20
Product CodeCAF
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

ULTRASONIC NEBULIZER is the device name listed in this FDA 510(k) record. The listed applicant is Foshan Gaunying Electronics Co., Ltd.. It received FDA 510(k) clearance on 2012-08-20 under 510(k) number K121154. 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 ULTRASONIC NEBULIZER?

ULTRASONIC NEBULIZER is a medical device that received FDA 510(k) clearance on 2012-08-20. The listed applicant is Foshan Gaunying Electronics Co., Ltd.. The 510(k) number is K121154.

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

ULTRASONIC NEBULIZER received FDA 510(k) clearance on 2012-08-20, under 510(k) number K121154.

Who is the listed applicant for ULTRASONIC NEBULIZER?

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

What is the FDA product code for ULTRASONIC NEBULIZER?

The FDA product code for ULTRASONIC NEBULIZER is CAF.

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Other records listing Foshan Gaunying Electronics 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.

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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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