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FDA 510(k)

SYSTEMS FLOW 2000

K-Number: K902993 · 1990-12-24

ApplicantUniversal Hydrotech, Inc.
Decision Date1990-12-24
Product CodeKPL
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

SYSTEMS FLOW 2000 is the device name listed in this FDA 510(k) record. The listed applicant is Universal Hydrotech, Inc.. It received FDA 510(k) clearance on 1990-12-24 under 510(k) number K902993. The device is classified under product code KPL. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SYSTEMS FLOW 2000?

SYSTEMS FLOW 2000 is a medical device that received FDA 510(k) clearance on 1990-12-24. The listed applicant is Universal Hydrotech, Inc.. The 510(k) number is K902993.

When did SYSTEMS FLOW 2000 receive FDA 510(k) clearance?

SYSTEMS FLOW 2000 received FDA 510(k) clearance on 1990-12-24, under 510(k) number K902993.

Who is the listed applicant for SYSTEMS FLOW 2000?

The FDA 510(k) record lists Universal Hydrotech, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for SYSTEMS FLOW 2000?

The FDA product code for SYSTEMS FLOW 2000 is KPL.

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Related Devices (Code: KPL)

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.

K201861Bio Fluff SystemGnali Bocia S.R.L.K180800Colonic Plus Regular, Small, and Straight Shape HydrokitColonic PlusK152834Colonplus Colonkit small, Colonplus Colonkit large, Colonplus Colonkit with Stop Collar 6, Colonplus Colonkit with Stop Collar 10Colonplus Equipments & Speculums, S.L.K094022THE WATER LILYClearwater Products, LLCK071057COLONIC & ENEMA NOZZLETiller Mind Body, Inc.K051344COLONIC AND ENEMA NOZZLEUltimate Concepts, Inc.

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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