Proprietary Name: |
Andesfit Limited ADF-B19 |
Classification Name: |
SYSTEM, MEASUREMENT, BLOOD-PRESSURE, NON-INVASIVE |
Product Code: |
DXN |
Device Class: |
2 |
Regulation Number: |
870.1130 |
Medical Specialty: |
Cardiovascular |
Registered Establishment Name: |
ANDESFIT LIMITED
|
Registered Establishment Number: |
3014074923
|
Premarket Submission Number: |
K161846 |
Owner/Operator: |
ANDESFIT LIMITED |
Owner/Operator Number: |
10057989
|
Establishment Operations: |
Foreign Exporter; Foreign Private Label Distributor
|