K760931 is an FDA 510(k) clearance for the I.V. DRIP MONITOR ALARM DEVICE, MONIFLO. This device is classified as a Monitor, Electric For Gravity Flow Infusion Systems (Class II - Special Controls, product code FLN).
Submitted by Diemolding Corp. (Mchenry, US). The FDA issued a Cleared decision on January 5, 1977, 68 days after receiving the submission on October 29, 1976.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 880.2420.
| 510(k) Number | K760931 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | October 29, 1976 |
| Decision Date | January 05, 1977 |
| Days to Decision | 68 days |
| Submission Type | Traditional |
| Review Panel | General Hospital (HO) |
| Summary | — |
| Product Code | FLN — Monitor, Electric For Gravity Flow Infusion Systems |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 880.2420 |