K834528 is an FDA 510(k) clearance for the MODEL 2001 INTELLIGENT INFUSOR. This device is classified as a Controller, Infusion, Intravascular, Electronic (Class II - Special Controls, product code LDR).
Submitted by Quest Medical, Inc. (Mchenry, US). The FDA issued a Cleared decision on February 21, 1984, 62 days after receiving the submission on December 21, 1983.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 880.5725.
| 510(k) Number | K834528 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | December 21, 1983 |
| Decision Date | February 21, 1984 |
| Days to Decision | 62 days |
| Submission Type | Traditional |
| Review Panel | General Hospital (HO) |
| Summary | — |
| Product Code | LDR — Controller, Infusion, Intravascular, Electronic |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 880.5725 |