Proprietary Name: |
989803192551 Clear Tape Wet Gel ECG Electrode; M4612A Solid Gel Foam Electrode; M4613A Solid Gel Foam Electrode |
Classification Name: |
ELECTRODE, ELECTROCARDIOGRAPH |
Product Code: |
DRX |
Device Class: |
2 |
Regulation Number: |
870.2360 |
Medical Specialty: |
Cardiovascular |
Registered Establishment Name: |
Philips North America LLC
|
Registered Establishment Number: |
1218950
|
Premarket Submission Number: |
K023503 |
Owner/Operator: |
Philips Medical Systems International BV |
Owner/Operator Number: |
1217116
|
Establishment Operations: |
Repackager/Relabeler
|