Betaflo 2000 Piggyback System
FDA 510(k) K864789 · Betaflo, Inc.
510(k) numberK864789
Submission
- Device name
- Betaflo 2000 Piggyback System
- Applicant
- Betaflo, Inc.
Menlo Park, CA, US - Received
- December 8, 1986
- Decision date
- February 4, 1987
- 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 |
| 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 |
|---|---|---|
| K862273 | Betaflo 2000LDR · Traditional | 07/18/1986SE |
Questions and answers
When was Betaflo 2000 Piggyback System cleared by the FDA?
Betaflo 2000 Piggyback System (K864789) received a 510(k) decision of Substantially Equivalent on February 4, 1987, 58 days after the submission was received.
What is the product code of K864789?
The FDA product code is LDR – Controller, Infusion, Intravascular, Electronic, a Class II (moderate risk) device regulated under 21 CFR 880.5725.