Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR, NMPA) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

Electronic Sphygmomanometer

K-Number: K160349 · 2016-11-03

Decision Date2016-11-03
Product CodeDXN
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

Electronic Sphygmomanometer is a medical device manufactured by Guangdong Biolight Meditech Co., Ltd.. It received FDA 510(k) clearance on 2016-11-03 under approval 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. It is manufactured by Guangdong Biolight Meditech Co., Ltd.. The 510(k) number is K160349.

When was Electronic Sphygmomanometer approved by the FDA?

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

What company makes Electronic Sphygmomanometer?

Electronic Sphygmomanometer is manufactured by Guangdong Biolight Meditech Co., Ltd..

What is the FDA product code for Electronic Sphygmomanometer?

The FDA product code for Electronic Sphygmomanometer is DXN.

Other Devices by Guangdong Biolight Meditech Co., Ltd.

View all 8 devices →

Related Devices (Code: DXN)

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.