SYNETEC


information about

Device Classification Name

computer, diagnostic, programmable

510(k) Number K002817
Device Name SYNETEC
Original Applicant
ELA MEDICAL, INC.
2950 xenium ln. north, #120
plymouth, 
MN 
55441

Original Contact susan olive
Regulation Number 870.1425
Classification Product Code
DQK  
Date Received 09/11/2000
Decision Date 05/02/2001
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Cardiovascular

510k Review Panel

Cardiovascular

Type Traditional
Reviewed by Third Party No

Combination Product

No