The following data is part of a premarket notification filed by Em-tec Gmbh with the FDA for Low Fluid Alarm.
| Device ID | K080704 |
| 510k Number | K080704 |
| Device Name: | LOW FLUID ALARM |
| Classification | Monitor, Electric For Gravity Flow Infusion Systems |
| Applicant | EM-TEC GMBH LERCHENBERG 20 Finning, Bavaria, DE 86923 |
| Contact | Bernhard Brand |
| Correspondent | Stefan Preiss TUV SUD AMERICA INC. 1775 OLD HIGHWAY 8 NW New Brighton, MN 55112 -1891 |
| Product Code | FLN |
| CFR Regulation Number | 880.2420 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Abbreviated |
| 3rd Party Reviewed | Yes |
| Combination Product | No |
| Date Received | 2008-03-12 |
| Decision Date | 2008-04-17 |