AUREFLO MONITORING SYSTEM


Device Classification Name

flowmeter, blood, cardiovascular

510(k) Number K112657
Device Name AUREFLO MONITORING SYSTEM
Applicant
TRANSONIC SYSTEMS, INC.
34 dutch mill rd.
ithaca, 
NY 
14850

Applicant Contact david klementowski
Correspondent
TRANSONIC SYSTEMS, INC.
34 dutch mill rd.
ithaca, 
NY 
14850

Correspodent Contact david klementowski
Regulation Number 870.2100
Classification Product Code
DPW  
Date Received 09/13/2011
Decision Date 12/21/2011
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Cardiovascular

510k Review Panel

Cardiovascular

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No