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
|
|
Correspondent Contact |
TANIA OTTEBRINK |
Regulation Number | 870.2300
|
Classification Product Code |
|
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
|
Recalls |
CDRH Recalls
|
|
|