Tumbler, General Medical Medi-Pak
FDA 510(k) K760491 · Landmark Plastics
510(k) numberK760491
Submission
- Device name
- Tumbler, General Medical Medi-Pak
- Applicant
- Landmark Plastics
Walker, MI, US - Received
- August 23, 1976
- Decision date
- September 15, 1976
- 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
Other 510(k)s with product code LDR
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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 |
More from The Master Medical Corp.
| 510(k) | Device | Decision |
|---|---|---|
| K760552 | Thermometer Stand and Dust CoverFLK · Traditional | 11/12/1976SE |
| K760548 | Carafe and Liner · Traditional | 11/12/1976SE |
| K760517 | Cup, Disposable MedicineKYX · Traditional | 11/12/1976SE |
| K760497 | Tray, ServiceLRP · Traditional | 11/12/1976SE |
| K760496 | Cup, Disposable SpecimenFMH · Traditional | 11/12/1976SE |
| K760495 | Basin, Rectangular WashFNY · Traditional | 11/12/1976SE |
| K760494 | Basin, Round WashFNY · Traditional | 11/12/1976SE |
| K760493 | Dish, Soap · Traditional | 11/12/1976SE |
| K760492 | Basin, Large or SmallFNY · Traditional | 11/12/1976SE |
| K760490 | Bedpan, General Medical Medi-PakFOB · Traditional | 11/12/1976SE |
Questions and answers
When was Tumbler, General Medical Medi-Pak cleared by the FDA?
Tumbler, General Medical Medi-Pak (K760491) received a 510(k) decision of Substantially Equivalent on September 15, 1976, 23 days after the submission was received.
What is the product code of K760491?
The FDA product code is LDR – Controller, Infusion, Intravascular, Electronic, a Class II (moderate risk) device regulated under 21 CFR 880.5725.