The following data is part of a premarket notification filed by Quest Medical, Inc. with the FDA for Model 2001 Intelligent Infusor.
| Device ID | K834528 |
| 510k Number | K834528 |
| Device Name: | MODEL 2001 INTELLIGENT INFUSOR |
| Classification | Controller, Infusion, Intravascular, Electronic |
| Applicant | QUEST MEDICAL, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | LDR |
| CFR Regulation Number | 880.5725 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1983-12-21 |
| Decision Date | 1984-02-21 |