Device Classification Name |
Electrode, Cutaneous
|
510(k) Number |
K151033 |
Device Name |
Philips Self-Adhesive Electrodes |
Applicant |
PHILIPS CONSUMER LIFESTYLE |
1600 SUMMER STREET |
STAMFORD,
CT
06905
|
|
Applicant Contact |
MARTA WALKER |
Correspondent |
PHILIPS CONSUMER LIFESTYLE |
1600 SUMMER STREET |
STAMFORD,
CT
06905
|
|
Correspondent Contact |
MARTA WALKER |
Regulation Number | 882.1320
|
Classification Product Code |
|
Date Received | 04/17/2015 |
Decision Date | 07/28/2015 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Neurology
|
510k Review Panel |
Neurology
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|