DK*300 Volumetric Infusion Controller
FDA 510(k) K843254 · Deka Research & Development Corp.
510(k) numberK843254
Submission
- Device name
- DK*300 Volumetric Infusion Controller
- Applicant
- Deka Research & Development Corp.
Manchester, NH, US - Received
- August 20, 1984
- Decision date
- October 11, 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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|---|---|---|---|
| K242693 | DEKA Infusion System, DEKA Administration SetLDR · Special | Deka Research and Development Corporation | 10/07/2024SE |
| K232316 | DEKA Infusion System, DEKA Administration SetLDR · Traditional | Deka Research and Development | 03/01/2024SE |
| K153760 | Volumetric Infusion ControllerLDR · Traditional | DEKA Research & Development | 10/03/2016SE |
| K963136 | Pacer Model 100 Infusion ControllerLDR · Traditional | Health Watch, Inc. | 10/10/1997SE |
| K971865 | Alexander Manufacturing Co. Rechargeable Battery Part Number M12/500-3PLDR · Traditional | Alexander Mfg. Co. | 07/03/1997SE |
| K971826 | Alexander Manufacturing Co. Rechargeable Battery Part Number M12/500LDR · Traditional | Alexander Mfg. Co. | 07/03/1997SE |
| K934543 | Universal Controller, Model 100LDR · Traditional | Metamed, Inc. | 03/29/1994SE |
| K935236 | Flow Controlling Extension SetLDR · Traditional | Block Medical, Inc. | 02/24/1994SE |
| K905498 | Stat 2 IV PumpetteLDR · Traditional | The Master Medical Corp. | 04/16/1991SE |
| K905497 | Master Flow I.V. PumpetteLDR · Traditional | The Master Medical Corp. | 04/16/1991SE |
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| K172601 | Next Generation iBOTIMK · Traditional | 03/02/2018SE |
| K153760 | Volumetric Infusion ControllerLDR · Traditional | 10/03/2016SE |
| K124018 | Amia Automated PD SystemFKX · Traditional | 06/14/2013SE |
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Questions and answers
When was DK*300 Volumetric Infusion Controller cleared by the FDA?
DK*300 Volumetric Infusion Controller (K843254) received a 510(k) decision of Substantially Equivalent on October 11, 1984, 52 days after the submission was received.
What is the product code of K843254?
The FDA product code is LDR – Controller, Infusion, Intravascular, Electronic, a Class II (moderate risk) device regulated under 21 CFR 880.5725.