K830605 is an FDA 510(k) clearance for the PUMP PALL AMBULATORY INSULIN INFUSION. This device is classified as a Pump, Infusion (Class II - Special Controls, product code FRN).
Submitted by Biomedical Devices, Inc. (Mchenry, US). The FDA issued a Cleared decision on March 31, 1983, 34 days after receiving the submission on February 25, 1983.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 880.5725.
| 510(k) Number | K830605 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | February 25, 1983 |
| Decision Date | March 31, 1983 |
| Days to Decision | 34 days |
| Submission Type | Traditional |
| Review Panel | General Hospital (HO) |
| Summary | — |
| Product Code | FRN — Pump, Infusion |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 880.5725 |