AO USB RECEIVER, WI-BOX, WI-BOX PSU KIT, WI-BOX XPRESS CABLE, PW USB RECEIVER


Device Classification Name

transmitters and receivers, physiological signal, radiofrequency

510(k) Number K111854
Device Name AO USB RECEIVER, WI-BOX, WI-BOX PSU KIT, WI-BOX XPRESS CABLE, PW USB RECEIVER
Applicant
ST. JUDE MEDICAL SYSTEMS AB
palmbladsgatan 10
uppsala, 

SE

se-751 35

Applicant Contact mikael sjolander
Correspondent
ST. JUDE MEDICAL SYSTEMS AB
palmbladsgatan 10
uppsala, 

SE

se-751 35

Correspodent Contact mikael sjolander
Regulation Number 870.2910
Classification Product Code
DRG  
Date Received 06/29/2011
Decision Date 10/21/2011
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Cardiovascular

510k Review Panel

Cardiovascular

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No