K080704 is an FDA 510(k) clearance for the LOW FLUID ALARM. This device is classified as a Monitor, Electric For Gravity Flow Infusion Systems (Class II - Special Controls, product code FLN).
Submitted by Em-Tec GmbH (Finning, Bavaria, DE). The FDA issued a Cleared decision on April 17, 2008, 36 days after receiving the submission on March 12, 2008.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 880.2420.
| 510(k) Number | K080704 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | March 12, 2008 |
| Decision Date | April 17, 2008 |
| Days to Decision | 36 days |
| Submission Type | Abbreviated |
| Review Panel | General Hospital (HO) |
| Summary | Statement |
| Product Code | FLN — Monitor, Electric For Gravity Flow Infusion Systems |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 880.2420 |