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U.S. Department of Health and Human Services

Establishment Registration & Device Listing

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Proprietary Name: BK-IS4/DF4; D-KIT; D2-KIT; DH DF4; ICS 3000; Kainox VCS; Linox; Linoxsmart; PA-10; PA-11; Protego; PSW 1301.U; Renamic; Vigila; Volta
Classification Name: PROGRAMMER, PACEMAKER
Product Code: KRG
Device Class: 3
Regulation Number: 870.3700
Medical Specialty: Cardiovascular
Registered Establishment Name: BIOTRONIK SE & CO. KG
Registered Establishment Number: 9610139
Owner/Operator: BIOTRONIK SE & CO. KG
Owner/Operator Number: 9018331
Establishment Operations: Manufacturer