| Proprietary Name: |
Amvia; BS IS-1 Blind Plug; CardioMessenger; Dextrus; DH; Ecuro; Edora; EDP; Effecta; EFH; EFH-6F-W; Eluna; Entovis; Estella; Etrinsa; Evia; Evity; HMSC 3.55.0; HMSC Version 3.39; HMSC Version 3.40; HMSC Version 3.41; HMSC Version 3.42; HMSC Version 3.43; HMSC Version 3.44; HMSC Version 3.45; HMSC Version 3.47; HMSC Version 3.48; HMSC Version 3.53; HMSC Version 3.54; HMSC Version 3.57; HMSC Version 3.58; HMSC Version 3.60.0; HMSC Version 3.62; HMSC Version 3.63; HMSC Version 3.64; HMSC Version 3.64.1; HMSC Version 3.65; HMSC Version 3.65.1; Home Monitoring; ICS 3000; M-50 Magnet; Model 3145; Model 3150; Model 3171; Model 3175; Model 6646; Model 6652; Model 6653; NEO 2100.U; NEO 2201.U/1; NEO 2202.U; NEO 2204.U; NEO 2301.U; NEO 2302.U; NEO 2303.U; NEO 2401.U; NEO 2401.U/1; NK-29; P-KIT; PK-155; PK-155-B; PK-175; PK-222; PK-222-L ECG Cable; PK-83; PSW 1506.U; PSW 1506.U/1; PSW 1507.U; PSW 1702.U; PSW 1703.U; PSW 1704.U; PSW 1801.U; PSW 1804.U; PSW 1901.U; PSW 1904.U; PSW 2100.U; PSW 2100.U/1; PSW 2201.U/1; PSW 2202.U; PSW 2204.U; PSW 2301.U; PSW 2302.U; PSW 2303.U; PSW 2401.U; Reliaty; Renamic; Renamic Neo NEOexpress; Renamic Neo Programmer; Reocor; S 45; S 53; S 58; S 60; Safio; Selox; Setrox S; Solia; Solia CSP S 53; Solia CSP S 60; Solia T/JT; Solox; Solvia; Tilda |
| Classification Name: |
PROGRAMMER, PACEMAKER |
| Product Code: |
KRG |
| Device Class: |
3 |
| Regulation Number: |
870.3700 |
| Medical Specialty: |
Cardiovascular |
| Registered Establishment Name: |
BIOTRONIK, INC.
|
| Registered Establishment Number: |
1028232
|
| Premarket Submission Number: |
P950037 |
| Owner/Operator: |
BIOTRONIK, INC. |
| Owner/Operator Number: |
1028232
|
| Establishment Operations: |
Repackager/Relabeler
|
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