K993972 is an FDA 510(k) clearance for the DISPOSABLE INFUSION PUMP KIT. This device is classified as a Pump, Infusion, Elastomeric (Class II - Special Controls, product code MEB).
Submitted by Biomet, Inc. (Warsaw, US). The FDA issued a Cleared decision on February 7, 2000, 76 days after receiving the submission on November 23, 1999.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 880.5725.
| 510(k) Number | K993972 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | November 23, 1999 |
| Decision Date | February 07, 2000 |
| Days to Decision | 76 days |
| Submission Type | Traditional |
| Review Panel | General Hospital (HO) |
| Summary | Summary PDF |
| Product Code | MEB — Pump, Infusion, Elastomeric |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 880.5725 |