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FDA 510(k)

FlowKeepers

K-Number: K160323 · 2017-04-06

ApplicantDk Electronics, LLC
Decision Date2017-04-06
Product CodeNGX
Advisory CommitteePM
DecisionSubstantially Equivalent

Device Summary

FlowKeepers is the device name listed in this FDA 510(k) record. The listed applicant is Dk Electronics, LLC. It received FDA 510(k) clearance on 2017-04-06 under 510(k) 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. The listed applicant is Dk Electronics, LLC. The 510(k) number is K160323.

When did FlowKeepers receive FDA 510(k) clearance?

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

Who is the listed applicant for FlowKeepers?

The FDA 510(k) record lists Dk Electronics, LLC as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for FlowKeepers?

The FDA product code for FlowKeepers is NGX.

Related Devices (Code: NGX)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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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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