K932408 is an FDA 510(k) clearance for the AMBULATORY INFUSION PUMP SYSTEM AND SOLUTION SETS. This device is classified as a Clamp, Non-electrical (Class I - General Controls, product code FFN).
Submitted by Baxter Healthcare Corp (Round Lake, US). The FDA issued a Cleared decision on September 28, 1993, 133 days after receiving the submission on May 18, 1993.
This device falls under the Gastroenterology & Urology FDA review panel. Regulated under 21 CFR 876.4730.
| 510(k) Number | K932408 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | May 18, 1993 |
| Decision Date | September 28, 1993 |
| Days to Decision | 133 days |
| Submission Type | Traditional |
| Review Panel | Gastroenterology & Urology (GU) |
| Summary | Summary PDF |
| Product Code | FFN — Clamp, Non-electrical |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 876.4730 |