Stand, Infusion
FDA 510(k) K946201 · Medical Specialties, Inc.
510(k) numberK946201
Submission
- Device name
- Stand, Infusion
- Applicant
- Medical Specialties, Inc.
South Easton, MA, US - Received
- December 21, 1994
- Decision date
- April 18, 1995
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
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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|---|---|---|---|
| K980336 | IV StandsFOX · Traditional | Clinton Industries, Inc. | 04/06/1998SE |
| K964782 | Medrad Contrast HolderFOX · Traditional | Medrad, Inc. | 02/25/1997SE |
| K961470 | Port-A-PoleFOX · Traditional | Prins Medical Ind., Inc. | 07/22/1996SE |
| K960027 | High Volume I.V. & Irrigation TowerFOX · Traditional | Allen Medical Systems, Inc. | 03/12/1996SE |
| K952196 | IV Pole/StandFOX · Traditional | Valentine Intl. , Ltd. | 07/31/1995SE |
| K950367 | IV ShuttleFOX · Traditional | Equipment Concepts, Inc. | 04/26/1995SE |
| K944580 | Flexsys Mobilemate Equipment StandFOX · Traditional | Hill-Rom, Inc. | 03/17/1995SE |
| K932498 | Mobile Care IV StandFOX · Traditional | Mobile Care, Inc. | 10/27/1993SE |
| K925066 | Pneumatic Irrigation StandardFOX · Traditional | Arthrodyn, Inc. | 07/28/1993SE |
| K912010 | I.V. Sky-HookFOX · Traditional | Dina - Industria, Comercio E Exportacao , Ltd. | 08/19/1991SE |
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| K896566 | Modified Fox Extra Gram Negative and PositiveJWY · Traditional | 02/09/1990SE |
| K883851 | Msi-Cal 8KRZ · Traditional | 11/22/1988SE |
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| K883703 | Msi-Cal 7KRZ · Traditional | 11/22/1988SE |
| K880608 | Msi-PcGJP · Traditional | 03/21/1988SE |
| K880270 | Msi-Diff PlusJPK · Traditional | 03/01/1988SE |
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Questions and answers
When was Stand, Infusion cleared by the FDA?
Stand, Infusion (K946201) received a 510(k) decision of Substantially Equivalent on April 18, 1995, 118 days after the submission was received.
What is the product code of K946201?
The FDA product code is FOX – Stand, Infusion, a Class I (low risk) device regulated under 21 CFR 880.6990.