Rateminder II Specialty Care
FDA 510(k) K833520 · Anatros Corp.
510(k) numberK833520
Submission
- Device name
- Rateminder II Specialty Care
- Applicant
- Anatros Corp.
Mchenry, IL, US - Received
- October 11, 1983
- Decision date
- December 22, 1983
- 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
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| 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 |
|---|---|---|
| K812233 | RateminderLDR · Traditional | 08/25/1981SE |
Questions and answers
When was Rateminder II Specialty Care cleared by the FDA?
Rateminder II Specialty Care (K833520) received a 510(k) decision of Substantially Equivalent on December 22, 1983, 72 days after the submission was received.
What is the product code of K833520?
The FDA product code is LDR – Controller, Infusion, Intravascular, Electronic, a Class II (moderate risk) device regulated under 21 CFR 880.5725.