Device Classification Name |
electrode, electrocardiograph
|
510(k) Number |
K092744 |
Device Name |
NEONATAL ECG ELECTRODE, M203KEN |
Applicant |
R & D MEDICAL PRODUCTS, INC. |
20492 CRESCENT BAY DR. #106 |
LAKE FOREST,
CA
92630
|
|
Applicant Contact |
JAMES PERRAULT |
Correspondent |
R & D MEDICAL PRODUCTS, INC. |
20492 CRESCENT BAY DR. #106 |
LAKE FOREST,
CA
92630
|
|
Correspondent Contact |
JAMES PERRAULT |
Regulation Number | 870.2360
|
Classification Product Code |
|
Date Received | 09/08/2009 |
Decision Date | 12/10/2009 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Cardiovascular
|
510k Review Panel |
Cardiovascular
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|