Treonic C30
FDA 510(k) K840823 · Vickers America Medical Corp.
510(k) numberK840823
Submission
- Device name
- Treonic C30
- Applicant
- Vickers America Medical Corp.
Mchenry, IL, US - Received
- February 24, 1984
- Decision date
- March 23, 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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More from The Master Medical Corp.
| 510(k) | Device | Decision |
|---|---|---|
| K831838 | Laboratory Data MGMT System SDMSJQP · Traditional | 01/24/1984SE |
| K830748 | ResuscitaireFMT · Traditional | 06/22/1983SE |
| K830936 | Treonic IP5FRN · Traditional | 04/12/1983SE |
| K813239 | Oxygenaire Nuring IncubatorFMZ · Traditional | 01/28/1982SE |
| K813238 | Neocare Baby-Controlled IncubatorFMZ · Traditional | 01/22/1982SE |
| K811865 | Vma Pediatric Apnea MattressBZQ · Traditional | 07/31/1981SE |
| K810792 | Neocare Temperature MonitorFMZ · Traditional | 04/29/1981SE |
| K810571 | Neocare Oxygen MonitorCCL · Traditional | 03/11/1981SE |
| K810067 | 140 Neocare Air Controlled IncubatorFMZ · Traditional | 03/11/1981SE |
| K802251 | SP 120 SophisticateJQP · Traditional | 10/23/1980SE |
Questions and answers
When was Treonic C30 cleared by the FDA?
Treonic C30 (K840823) received a 510(k) decision of Substantially Equivalent on March 23, 1984, 28 days after the submission was received.
What is the product code of K840823?
The FDA product code is LDR – Controller, Infusion, Intravascular, Electronic, a Class II (moderate risk) device regulated under 21 CFR 880.5725.