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FDA 510(k)

Electronic Sphygmomanometer

K-Number: K160349 · 2016-11-03

ApplicantGuangdong Biolight Meditech Co., Ltd.
Decision Date2016-11-03
Product CodeDXN
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

Electronic Sphygmomanometer is the device name listed in this FDA 510(k) record. The listed applicant is Guangdong Biolight Meditech Co., Ltd.. It received FDA 510(k) clearance on 2016-11-03 under 510(k) number K160349. The device is classified under product code DXN. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Electronic Sphygmomanometer?

Electronic Sphygmomanometer is a medical device that received FDA 510(k) clearance on 2016-11-03. The listed applicant is Guangdong Biolight Meditech Co., Ltd.. The 510(k) number is K160349.

When did Electronic Sphygmomanometer receive FDA 510(k) clearance?

Electronic Sphygmomanometer received FDA 510(k) clearance on 2016-11-03, under 510(k) number K160349.

Who is the listed applicant for Electronic Sphygmomanometer?

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

What is the FDA product code for Electronic Sphygmomanometer?

The FDA product code for Electronic Sphygmomanometer is DXN.

Other records listing Guangdong Biolight Meditech Co., Ltd. as applicant

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Related Devices (Code: DXN)

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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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