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FDA 510(k)

ELECTROSURGICAL GENERATOR

K-Number: K130760 · 2013-09-16

ApplicantBeijing Jinhengwei Technology Development Co., Ltd.
Decision Date2013-09-16
Product CodeGEI
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

ELECTROSURGICAL GENERATOR is the device name listed in this FDA 510(k) record. The listed applicant is Beijing Jinhengwei Technology Development Co., Ltd.. It received FDA 510(k) clearance on 2013-09-16 under 510(k) number K130760. The device is classified under product code GEI. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ELECTROSURGICAL GENERATOR?

ELECTROSURGICAL GENERATOR is a medical device that received FDA 510(k) clearance on 2013-09-16. The listed applicant is Beijing Jinhengwei Technology Development Co., Ltd.. The 510(k) number is K130760.

When did ELECTROSURGICAL GENERATOR receive FDA 510(k) clearance?

ELECTROSURGICAL GENERATOR received FDA 510(k) clearance on 2013-09-16, under 510(k) number K130760.

Who is the listed applicant for ELECTROSURGICAL GENERATOR?

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

What is the FDA product code for ELECTROSURGICAL GENERATOR?

The FDA product code for ELECTROSURGICAL GENERATOR is GEI.

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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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