K951988 is an FDA 510(k) clearance for the PRESSURIZER. This device is classified as a Infusor, Pressure, For I.v. Bags (Class I - General Controls, product code KZD).
Submitted by Promedic, Inc. (Indianapolis, US). The FDA issued a Cleared decision on June 14, 1995, 48 days after receiving the submission on April 27, 1995.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 880.5420.
| 510(k) Number | K951988 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | April 27, 1995 |
| Decision Date | June 14, 1995 |
| Days to Decision | 48 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 |