510(k) K080704
K080704 is an FDA 510(k) premarket notification submitted by Em-Tec GmbH for the device "LOW FLUID ALARM". The FDA issued a decision of Substantially Equivalent on April 17, 2008. The device falls under product code FLN (Monitor, Electric For Gravity Flow Infusion Systems), a Class II device regulated under 21 CFR 880.2420. Em-Tec GmbH has at least 2 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- April 17, 2008
- Date Received
- March 12, 2008
- Clearance Type
- Abbreviated
- Expedited Review
- No
- Third Party Review
- Yes
Device Classification
- Device Name
- Monitor, Electric For Gravity Flow Infusion Systems
- Device Class
- Class II
- Regulation Number
- 880.2420
- Review Panel
- HO
- Submission Type