K980165 is an FDA 510(k) clearance for the INFUTEST 2000 INFUSION DEVICE ANALYZER. This device is classified as a Accessories, Pump, Infusion (Class II - Special Controls, product code MRZ).
Submitted by Datrend Systems, Inc. (Burnaby, British Columbia, CA). The FDA issued a Cleared decision on April 20, 1998, 94 days after receiving the submission on January 16, 1998.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 880.5725.
| 510(k) Number | K980165 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | January 16, 1998 |
| Decision Date | April 20, 1998 |
| Days to Decision | 94 days |
| Submission Type | Traditional |
| Review Panel | General Hospital (HO) |
| Summary | Summary PDF |
| Product Code | MRZ — Accessories, Pump, Infusion |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 880.5725 |