510(k) K111730
K111730 is an FDA 510(k) premarket notification submitted by Em-Tec GmbH for the device "SONOTT FLOWLAB(R)". The FDA issued a decision of Substantially Equivalent on January 6, 2012. The device falls under product code DPW (Flowmeter, Blood, Cardiovascular), a Class II device regulated under 21 CFR 870.2100. Em-Tec GmbH has at least 2 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- January 6, 2012
- Date Received
- June 20, 2011
- Clearance Type
- Abbreviated
- Expedited Review
- No
- Third Party Review
- Yes
Device Classification
- Device Name
- Flowmeter, Blood, Cardiovascular
- Device Class
- Class II
- Regulation Number
- 870.2100
- Review Panel
- CV
- Submission Type