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)

FlowKeepers

K-Number: K160323 · 2017-04-06

Decision Date2017-04-06
Product CodeNGX
Advisory CommitteePM
DecisionSubstantially Equivalent

Device Summary

FlowKeepers is a medical device manufactured by Dk Electronics, LLC. It received FDA 510(k) clearance on 2017-04-06 under approval number K160323. The device is classified under product code NGX. It was reviewed by the PM advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the FlowKeepers?

FlowKeepers is a medical device that received FDA 510(k) clearance on 2017-04-06. It is manufactured by Dk Electronics, LLC. The 510(k) number is K160323.

When was FlowKeepers approved by the FDA?

FlowKeepers received FDA 510(k) clearance on 2017-04-06, under approval number K160323.

What company makes FlowKeepers?

FlowKeepers is manufactured by Dk Electronics, LLC.

What is the FDA product code for FlowKeepers?

The FDA product code for FlowKeepers is NGX.

Related Devices (Code: NGX)

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.