TRANSONIC SYRINGE WARMER, MODEL SYR-1000


Device Classification Name

system, hemodialysis, access recirculation monitoring

510(k) Number K022963
Device Name TRANSONIC SYRINGE WARMER, MODEL SYR-1000
Original Applicant
TRANSONIC SYSTEMS, INC.
34 dutch mill rd.
ithaca, 
NY 
14850

Original Contact mark s alsberge
Regulation Number 876.5820
Classification Product Code
MQS  
Date Received 09/06/2002
Decision Date 12/04/2002
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Gastroenterology/Urology

510k Review Panel

Gastroenterology/Urology

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No