The following data is part of a premarket notification filed by Dynatech/nevada, Inc. with the FDA for Model 404a I.v. Infusion Pump Analyzer.
| Device ID | K897096 |
| 510k Number | K897096 |
| Device Name: | MODEL 404A I.V. INFUSION PUMP ANALYZER |
| Classification | Pump, Infusion |
| Applicant | DYNATECH/NEVADA, INC. 2000 ARROWHEAD DR. Carson City, NV 89706 -0403 |
| Contact | D Hendricks |
| Correspondent | D Hendricks DYNATECH/NEVADA, INC. 2000 ARROWHEAD DR. Carson City, NV 89706 -0403 |
| Product Code | FRN |
| CFR Regulation Number | 880.5725 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1989-12-21 |
| Decision Date | 1990-03-15 |