The following data is part of a premarket notification filed by Datrend Systems, Inc. with the FDA for Infutest 2000 Infusion Device Analyzer.
| Device ID | K980165 |
| 510k Number | K980165 |
| Device Name: | INFUTEST 2000 INFUSION DEVICE ANALYZER |
| Classification | Accessories, Pump, Infusion |
| Applicant | DATREND SYSTEMS, INC. UNIT 106-3070 NORLAND AVE. Burnaby, British Columbia, CA V5b 3a6 |
| Contact | Ron Evans |
| Correspondent | Ron Evans DATREND SYSTEMS, INC. UNIT 106-3070 NORLAND AVE. Burnaby, British Columbia, CA V5b 3a6 |
| Product Code | MRZ |
| CFR Regulation Number | 880.5725 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1998-01-16 |
| Decision Date | 1998-04-20 |
| Summary: | summary |