Device Classification Name |
electrode, electrocardiograph
|
510(k) Number |
K101685 |
Device Name |
IP-SET |
Applicant |
INTEGRAL PROCESS SAS |
12 RUE DES CAYENNES |
PB 310 |
CONFLANS SAINTE HONORINE,
FR
78703
|
|
Applicant Contact |
CHRISTIAN BERTHON |
Correspondent |
TUV RHEINLAND OF NORTH AMERICA, INC. |
12 COMMERCE RD. |
NEWTON,
CT
06470
|
|
Correspondent Contact |
TAMAS BORSAI |
Regulation Number | 870.2360
|
Classification Product Code |
|
Date Received | 06/16/2010 |
Decision Date | 07/01/2010 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Cardiovascular
|
510k Review Panel |
Cardiovascular
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
Yes
|
Combination Product |
No
|
Recalls |
CDRH Recalls
|
|
|