Device Classification Name |
Transmitters And Receivers, Physiological Signal, Radiofrequency
|
510(k) Number |
K122285 |
Device Name |
TABLET COMMANDER |
Applicant |
CARDIOCOM LLC |
7980 CENTURY BLVD. |
CHANHASSEN,
MN
55317
|
|
Applicant Contact |
DANIEL L COSENTINO |
Correspondent |
REGULATORY TECHNOLOGY SERVICES, LLC |
1000 Westgate Drive, |
Suite 510k |
Saint Paul,
MN
55114
|
|
Correspondent Contact |
MARK JOB |
Regulation Number | 870.2910
|
Classification Product Code |
|
Date Received | 07/30/2012 |
Decision Date | 08/14/2012 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Cardiovascular
|
510k Review Panel |
Cardiovascular
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
Yes
|
Combination Product |
No
|
|
|