ASCOM CLINICALCONNEX CARDIOMAX


Device Classification Name

system,network and communication,physiological monitors

510(k) Number K103634
Device Name ASCOM CLINICALCONNEX CARDIOMAX
Applicant
ASCOM (US), INC.
po box 3018
nederland, 
CO 
80466

Applicant Contact thomas kroenke
Correspondent
ASCOM (US), INC.
po box 3018
nederland, 
CO 
80466

Correspodent Contact thomas kroenke
Regulation Number 870.2300
Classification Product Code
MSX  
Date Received 12/13/2010
Decision Date 02/23/2011
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Cardiovascular

510k Review Panel

Cardiovascular

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No