Pneumatic Irrigation Standard

FDA 510(k) K925066 · Arthrodyn, Inc.

Substantially Equivalent

510(k) numberK925066

Submission

Device name
Pneumatic Irrigation Standard
Applicant
Arthrodyn, Inc.
Madison, WI, US
Received
October 6, 1992
Decision date
July 28, 1993
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code
FOX – Stand, Infusion
Device class
Class I (low risk)
Regulation
21 CFR 880.6990
Specialty
General Hospital

Other 510(k)s with product code FOX

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K961470Port-A-PoleFOX · Traditional Prins Medical Ind., Inc.07/22/1996SE
K960027High Volume I.V. & Irrigation TowerFOX · Traditional Allen Medical Systems, Inc.03/12/1996SE
K952196IV Pole/StandFOX · Traditional Valentine Intl. , Ltd.07/31/1995SE
K950367IV ShuttleFOX · Traditional Equipment Concepts, Inc.04/26/1995SE
K946201Stand, InfusionFOX · Traditional Medical Specialties, Inc.04/18/1995SE
K944580Flexsys Mobilemate Equipment StandFOX · Traditional Hill-Rom, Inc.03/17/1995SE
K932498Mobile Care IV StandFOX · Traditional Mobile Care, Inc.10/27/1993SE
K912010I.V. Sky-HookFOX · Traditional Dina - Industria, Comercio E Exportacao , Ltd.08/19/1991SE

More from Dina - Industria, Comercio E Exportacao , Ltd.

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K924326Arthrodyn 45 Degree X-Ray TableIXR · Traditional 04/08/1993SE

Questions and answers

When was Pneumatic Irrigation Standard cleared by the FDA?

Pneumatic Irrigation Standard (K925066) received a 510(k) decision of Substantially Equivalent on July 28, 1993, 295 days after the submission was received.

What is the product code of K925066?

The FDA product code is FOX – Stand, Infusion, a Class I (low risk) device regulated under 21 CFR 880.6990.