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FDA 510(k)

BYTECH

K-Number: K130101 · 2013-11-08

ApplicantBytech Dongtai Co., Ltd.
Decision Date2013-11-08
Product CodeLYZ
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

BYTECH is the device name listed in this FDA 510(k) record. The listed applicant is Bytech Dongtai Co., Ltd.. It received FDA 510(k) clearance on 2013-11-08 under 510(k) number K130101. The device is classified under product code LYZ. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the BYTECH?

BYTECH is a medical device that received FDA 510(k) clearance on 2013-11-08. The listed applicant is Bytech Dongtai Co., Ltd.. The 510(k) number is K130101.

When did BYTECH receive FDA 510(k) clearance?

BYTECH received FDA 510(k) clearance on 2013-11-08, under 510(k) number K130101.

Who is the listed applicant for BYTECH?

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

What is the FDA product code for BYTECH?

The FDA product code for BYTECH is LYZ.

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Other records listing Bytech Dongtai Co., Ltd. as applicant

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.

K212899Disposable Vinyl/Nitrile Blend Medical Examination Gloves

Related Devices (Code: LYZ)

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Official Source

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

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