K935763 is an FDA 510(k) clearance for the SURGIPUMP. This device is classified as a Withdrawal/infusion Pump (Class II - Special Controls, product code DQI).
Submitted by W.O.M. World of Medicine GmbH (Tucson, US). The FDA issued a Cleared decision on April 21, 1994, 146 days after receiving the submission on November 26, 1993.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 870.1800.
| 510(k) Number | K935763 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | November 26, 1993 |
| Decision Date | April 21, 1994 |
| Days to Decision | 146 days |
| Submission Type | Traditional |
| Review Panel | General Hospital (HO) |
| Summary | Summary PDF |
| Product Code | DQI — Withdrawal/infusion Pump |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 870.1800 |