K901225 is an FDA 510(k) clearance for the LIFE SHIELD (DISPOSABLE PRESSURE INFUSOR). This device is classified as a Infusor, Pressure, For I.v. Bags (Class I - General Controls, product code KZD).
Submitted by Abbott Laboratories (Abbott Park, US). The FDA issued a Cleared decision on August 23, 1990, 162 days after receiving the submission on March 14, 1990.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 880.5420.
| 510(k) Number | K901225 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | March 14, 1990 |
| Decision Date | August 23, 1990 |
| Days to Decision | 162 days |
| Submission Type | Traditional |
| Review Panel | General Hospital (HO) |
| Summary | — |
| Product Code | KZD — Infusor, Pressure, For I.v. Bags |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 880.5420 |