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FDA 510(k)

KJ MASK

K-Number: K103019 · 2011-06-09

ApplicantKj Meditech Co., Ltd.
Decision Date2011-06-09
Product CodeDZB
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

KJ MASK is the device name listed in this FDA 510(k) record. The listed applicant is Kj Meditech Co., Ltd.. It received FDA 510(k) clearance on 2011-06-09 under 510(k) number K103019. The device is classified under product code DZB. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the KJ MASK?

KJ MASK is a medical device that received FDA 510(k) clearance on 2011-06-09. The listed applicant is Kj Meditech Co., Ltd.. The 510(k) number is K103019.

When did KJ MASK receive FDA 510(k) clearance?

KJ MASK received FDA 510(k) clearance on 2011-06-09, under 510(k) number K103019.

Who is the listed applicant for KJ MASK?

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

What is the FDA product code for KJ MASK?

The FDA product code for KJ MASK is DZB.

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Related Devices (Code: DZB)

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

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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