I.V. Sky-Hook
FDA 510(k) K912010 · Dina - Industria, Comercio E Exportacao , Ltd.
510(k) numberK912010
Submission
- Device name
- I.V. Sky-Hook
- Applicant
- Dina - Industria, Comercio E Exportacao , Ltd.
Miami, FL, US - Received
- May 6, 1991
- Decision date
- August 19, 1991
- 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
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| 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 |
| K946201 | Stand, InfusionFOX · Traditional | Medical Specialties, Inc. | 04/18/1995SE |
| 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 |
Questions and answers
When was I.V. Sky-Hook cleared by the FDA?
I.V. Sky-Hook (K912010) received a 510(k) decision of Substantially Equivalent on August 19, 1991, 105 days after the submission was received.
What is the product code of K912010?
The FDA product code is FOX – Stand, Infusion, a Class I (low risk) device regulated under 21 CFR 880.6990.