Proprietary Name: |
13951C Neonatal/Pediatric Solid Gel Electrode; 13952D Metallic Preattached Leadwire Electrode, Medium; 13953D Metallic Preattached Leadwire Electrode, Square; 13953E Radiolucent Preattached Leadwire Electrode, Square; 13955C Neonatal/Pediatric Snap Electrode, Square |
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: |
K871412 |
Owner/Operator: |
Philips Medical Systems International BV |
Owner/Operator Number: |
1217116
|
Establishment Operations: |
Repackager/Relabeler
|