SONOTT FLOWLAB(R)


Device Classification Name

flowmeter, blood, cardiovascular

510(k) Number K111730
Device Name SONOTT FLOWLAB(R)
Applicant
EM-TEC GMBH
lerchenberg 20
finning, 

DE

86923

Applicant Contact bernhard brand
Regulation Number 870.2100
Classification Product Code
DPW  
Subsequent Product Code
ITX  
Date Received 06/20/2011
Decision Date 01/06/2012
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Cardiovascular

510k Review Panel

Radiology

summary

summary

Type Abbreviated
Reviewed by Third Party Yes

Combination Product

No