ASCOM MOBILE MONITORING GATEWAY (MMG)

Device Classification Name

system,network and communication,physiological monitors

510(k) Number K111215
Device Name ASCOM MOBILE MONITORING GATEWAY (MMG)
Applicant
ASCOM (SWEDEN) AB
grimbodalen 2, p.o. box 8783
goteborg, 

SE

se-402-76
Applicant Contact tania ottebrink
Correspondent
ASCOM (SWEDEN) AB
grimbodalen 2, p.o. box 8783
goteborg, 

SE

se-402-76
Correspodent Contact tania ottebrink
Regulation Number 870.2300
Classification Product Code
MSX  
Date Received 05/02/2011
Decision Date 07/05/2011
Decision

substantially equivalent

(SESE)
Regulation Medical Specialty

Cardiovascular

510k Review Panel

Cardiovascular
summary

summary

Type Traditional
Reviewed by Third Party No
Combination Product

No