Device Classification Name |
detector and alarm, arrhythmia
|
510(k) Number |
K092947 |
Device Name |
TELESENTRY, MODEL TS01 |
Applicant |
SCOTTCARE CORPORATION |
4791 WEST 150TH ST. |
CLEVELAND,
OH
44135
|
|
Applicant Contact |
TIMOTHY J LEYVA |
Correspondent |
SCOTTCARE CORPORATION |
4791 WEST 150TH ST. |
CLEVELAND,
OH
44135
|
|
Correspondent Contact |
TIMOTHY J LEYVA |
Regulation Number | 870.1025
|
Classification Product Code |
|
Subsequent Product Code |
|
Date Received | 09/24/2009 |
Decision Date | 02/26/2010 |
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
|
|
|