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FDA 510(k)

COMPRESSOR NEBULIZER SYSTEM, MODEL KN-9321

K-Number: K051365 · 2005-07-22

ApplicantK-Jump Health Co., Ltd.
Decision Date2005-07-22
Product CodeCAF
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

COMPRESSOR NEBULIZER SYSTEM, MODEL KN-9321 is the device name listed in this FDA 510(k) record. The listed applicant is K-Jump Health Co., Ltd.. It received FDA 510(k) clearance on 2005-07-22 under 510(k) number K051365. 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 COMPRESSOR NEBULIZER SYSTEM, MODEL KN-9321?

COMPRESSOR NEBULIZER SYSTEM, MODEL KN-9321 is a medical device that received FDA 510(k) clearance on 2005-07-22. The listed applicant is K-Jump Health Co., Ltd.. The 510(k) number is K051365.

When did COMPRESSOR NEBULIZER SYSTEM, MODEL KN-9321 receive FDA 510(k) clearance?

COMPRESSOR NEBULIZER SYSTEM, MODEL KN-9321 received FDA 510(k) clearance on 2005-07-22, under 510(k) number K051365.

Who is the listed applicant for COMPRESSOR NEBULIZER SYSTEM, MODEL KN-9321?

The FDA 510(k) record lists K-Jump Health Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for COMPRESSOR NEBULIZER SYSTEM, MODEL KN-9321?

The FDA product code for COMPRESSOR NEBULIZER SYSTEM, MODEL KN-9321 is CAF.

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Official Source

View on FDA Database →

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

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