K864327 is an FDA 510(k) clearance for the MODEL 304-S EXTERNAL MICRO-VOLUME INFUSION PUMP. This device is classified as a Scale, Patient (Class I - General Controls, product code FRW).
Submitted by Medtronic Minimed (Sylmar, US). The FDA issued a Cleared decision on February 6, 1987, 94 days after receiving the submission on November 4, 1986.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 880.2720.
| 510(k) Number | K864327 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | November 04, 1986 |
| Decision Date | February 06, 1987 |
| Days to Decision | 94 days |
| Submission Type | Traditional |
| Review Panel | General Hospital (HO) |
| Summary | — |
| Product Code | FRW — Scale, Patient |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 880.2720 |