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)

NIBPCuff

K-Number: K231961 · 2023-08-30

Decision Date2023-08-30
Product CodeDXQ
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

NIBPCuff is a medical device manufactured by Shenzhen Sino-K Medical Technology Co.,Ltd. It received FDA 510(k) clearance on 2023-08-30 under approval number K231961. The device is classified under product code DXQ. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the NIBPCuff?

NIBPCuff is a medical device that received FDA 510(k) clearance on 2023-08-30. It is manufactured by Shenzhen Sino-K Medical Technology Co.,Ltd. The 510(k) number is K231961.

When was NIBPCuff approved by the FDA?

NIBPCuff received FDA 510(k) clearance on 2023-08-30, under approval number K231961.

What company makes NIBPCuff?

NIBPCuff is manufactured by Shenzhen Sino-K Medical Technology Co.,Ltd.

What is the FDA product code for NIBPCuff?

The FDA product code for NIBPCuff is DXQ.

Other Devices by Shenzhen Sino-K Medical Technology Co.,Ltd

Related Devices (Code: DXQ)

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.