| Proprietary Name: |
CardioMessenger; Dextrus; Ecuro; EDP; Effecta; Estella; Evia; Evtovis; Home Monitoring; ICS 3000; Model 3145; Model 3150; Model 3171; Model 3175; Model 6646; Model 6652; Model 6653; P-KIT; PSW 1203.U/1; Reliaty; Renamic; Reocor; Selox; Setrox S; Solox; Tilda |
| Classification Name: |
PULSE GENERATOR, EXTERNAL PACEMAKER, DUAL-CHAMBER |
| Product Code: |
OVJ |
| Device Class: |
3 |
| Regulation Number: |
870.3600 |
| Medical Specialty: |
Cardiovascular |
| Registered Establishment Name: |
BIOTRONIK, INC.
|
| Registered Establishment Number: |
1028232
|
| Owner/Operator: |
BIOTRONIK, INC. |
| Owner/Operator Number: |
1028232
|
| Establishment Operations: |
Repackager/Relabeler
|
|
|
