The following data is part of a premarket notification filed by Betaflo, Inc. with the FDA for Betaflo 2000.
| Device ID | K862273 |
| 510k Number | K862273 |
| Device Name: | BETAFLO 2000 |
| Classification | Controller, Infusion, Intravascular, Electronic |
| Applicant | BETAFLO, INC. 1060 MARSH RD. MENLO PARK, CA 94025 |
| Contact | WILLIAM E MAYA |
| Correspondent | WILLIAM E MAYA BETAFLO, INC. 1060 MARSH RD. MENLO PARK, CA 94025 |
| Product Code | LDR |
| Subsequent Product Code | New |
| CFR Regulation Number | 880.5725 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1986-06-16 |
| Decision Date | 1986-07-18 |