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FDA 510(k)

IS-III HActive Fixture

K-Number: K173938 · 2018-05-24

ApplicantNeobiotech Co., Ltd.
Decision Date2018-05-24
Product CodeDZE
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

IS-III HActive 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 2018-05-24 under 510(k) number K173938. 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 IS-III HActive Fixture?

IS-III HActive Fixture is a medical device that received FDA 510(k) clearance on 2018-05-24. The listed applicant is Neobiotech Co., Ltd.. The 510(k) number is K173938.

When did IS-III HActive Fixture receive FDA 510(k) clearance?

IS-III HActive Fixture received FDA 510(k) clearance on 2018-05-24, under 510(k) number K173938.

Who is the listed applicant for IS-III HActive 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 IS-III HActive Fixture?

The FDA product code for IS-III HActive 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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