Device Classification Name |
detector and alarm, arrhythmia
|
510(k) Number |
K142352 |
Device Name |
CardiacLinx |
Applicant |
Ross Medical Technology, Inc |
82 E. ALLENDALE ROAD, SUITE 8A |
saddle river,
NJ
07458
|
|
Applicant Contact |
alexander chiu |
Correspondent |
Ross Medical Technology, Inc |
82 E. ALLENDALE ROAD, SUITE 8A |
saddle river,
NJ
07458
|
|
Correspondent Contact |
alexander chiu |
Regulation Number | 870.1025
|
Classification Product Code |
|
Subsequent Product Codes |
|
Date Received | 08/22/2014 |
Decision Date | 03/12/2015 |
Decision |
substantially equivalent
(SESE) |
Regulation Medical Specialty |
Cardiovascular
|
510k Review Panel |
Cardiovascular
|
summary |
summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|