K974074 is an FDA 510(k) clearance for the INFUSION DYNAMICS POWER INFUSER. This device is classified as a Infusor, Pressure, For I.v. Bags (Class I - General Controls, product code KZD).
Submitted by Infusion Dynamics, Inc. (Princeton, US). The FDA issued a Cleared decision on February 17, 1998, 111 days after receiving the submission on October 29, 1997.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 880.5420.
| 510(k) Number | K974074 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | October 29, 1997 |
| Decision Date | February 17, 1998 |
| Days to Decision | 111 days |
| Submission Type | Traditional |
| Review Panel | General Hospital (HO) |
| Summary | Statement |
| Product Code | KZD — Infusor, Pressure, For I.v. Bags |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 880.5420 |