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FDA 510(k)

S-mini active Fixture

K-Number: K181178 · 2018-07-24

ApplicantNeobiotech Co., Ltd.
Decision Date2018-07-24
Product CodeDZE
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

S-mini active Fixture is the device name listed in this FDA 510(k) record. The listed applicant is Neobiotech Co., Ltd.. It received FDA 510(k) clearance on 2018-07-24 under 510(k) number K181178. The device is classified under product code DZE. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the S-mini active Fixture?

S-mini active Fixture is a medical device that received FDA 510(k) clearance on 2018-07-24. The listed applicant is Neobiotech Co., Ltd.. The 510(k) number is K181178.

When did S-mini active Fixture receive FDA 510(k) clearance?

S-mini active Fixture received FDA 510(k) clearance on 2018-07-24, under 510(k) number K181178.

Who is the listed applicant for S-mini active Fixture?

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

What is the FDA product code for S-mini active Fixture?

The FDA product code for S-mini active Fixture is DZE.

Other records listing Neobiotech Co., Ltd. as applicant

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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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