The following data is part of a premarket notification filed by American Edwards Laboratories with the FDA for Rateminder Iii Infusion Device.
| Device ID | K855000 |
| 510k Number | K855000 |
| Device Name: | RATEMINDER III INFUSION DEVICE |
| Classification | Controller, Infusion, Intravascular, Electronic |
| Applicant | AMERICAN EDWARDS LABORATORIES P.O. BOX 11150 17221 RED HILL AVE.(IRVINE) Santa Ana, CA 92711 -1150 |
| Contact | Daina Graham |
| Correspondent | Daina Graham AMERICAN EDWARDS LABORATORIES P.O. BOX 11150 17221 RED HILL AVE.(IRVINE) Santa Ana, CA 92711 -1150 |
| Product Code | LDR |
| CFR Regulation Number | 880.5725 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1985-12-13 |
| Decision Date | 1986-02-12 |