FDA 510(k)

GUAN HONG ULTRASONIC NEBULIZER, MODEL DR-103/AC-103

K-Number: K041079 · 2004-09-28

Decision Date2004-09-28

Product CodeCAF

Advisory CommitteeAN

DecisionSubstantially Equivalent

Device Summary

GUAN HONG ULTRASONIC NEBULIZER, MODEL DR-103/AC-103 is the device name listed in this FDA 510(k) record. The listed applicant is Guan Hong Enterprise Co., Ltd.. It received FDA 510(k) clearance on 2004-09-28 under 510(k) number K041079. 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 GUAN HONG ULTRASONIC NEBULIZER, MODEL DR-103/AC-103?

GUAN HONG ULTRASONIC NEBULIZER, MODEL DR-103/AC-103 is a medical device that received FDA 510(k) clearance on 2004-09-28. The listed applicant is Guan Hong Enterprise Co., Ltd.. The 510(k) number is K041079.

When did GUAN HONG ULTRASONIC NEBULIZER, MODEL DR-103/AC-103 receive FDA 510(k) clearance?

GUAN HONG ULTRASONIC NEBULIZER, MODEL DR-103/AC-103 received FDA 510(k) clearance on 2004-09-28, under 510(k) number K041079.

Who is the listed applicant for GUAN HONG ULTRASONIC NEBULIZER, MODEL DR-103/AC-103?

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

What is the FDA product code for GUAN HONG ULTRASONIC NEBULIZER, MODEL DR-103/AC-103?

The FDA product code for GUAN HONG ULTRASONIC NEBULIZER, MODEL DR-103/AC-103 is CAF.

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Official Source

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