Arm-A-Flow Intravenous Flow Regulator
FDA 510(k) K842209 · Armour Pharmaceutical Co.
510(k) numberK842209
Submission
- Device name
- Arm-A-Flow Intravenous Flow Regulator
- Applicant
- Armour Pharmaceutical Co.
Mchenry, IL, US - Received
- June 4, 1984
- Decision date
- December 4, 1984
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- LDR – Controller, Infusion, Intravascular, Electronic
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 880.5725
- Specialty
- General Hospital
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| K934543 | Universal Controller, Model 100LDR · Traditional | Metamed, Inc. | 03/29/1994SE |
| K935236 | Flow Controlling Extension SetLDR · Traditional | Block Medical, Inc. | 02/24/1994SE |
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| K844005 | Arm-A-Vial LV Heater-Breathing SysBZE · Traditional | 11/08/1984SE |
| K841991 | Arm-A-Care Humidifier-Respiratory GasCCQ · Traditional | 07/27/1984SE |
| K841990 | Arm-A-Care Nebulizer-NebulizerCCQ · Traditional | 07/27/1984SE |
| K841989 | Arm-A-Vial LV Sodium Chloride InhalatCCQ · Traditional | 07/27/1984SE |
| K841988 | Arm-A-Vial LV Sodium, Chloride InhalatCCQ · Traditional | 07/27/1984SE |
| K841987 | Arm-A-Vial LV Sterial Water for InhalaCCQ · Traditional | 07/27/1984SE |
Questions and answers
When was Arm-A-Flow Intravenous Flow Regulator cleared by the FDA?
Arm-A-Flow Intravenous Flow Regulator (K842209) received a 510(k) decision of Substantially Equivalent on December 4, 1984, 183 days after the submission was received.
What is the product code of K842209?
The FDA product code is LDR – Controller, Infusion, Intravascular, Electronic, a Class II (moderate risk) device regulated under 21 CFR 880.5725.