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U.S. Department of Health and Human Services

Establishment Registration & Device Listing
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Proprietary Name: BLOOM DTU ELECTROPHYS. PROG. STIMU; EPSTIM SOFTWARE; LATOR
Classification Name: GENERATOR, PULSE, PACEMAKER, EXTERNAL PROGRAMMABLE (FOR ELECTROPHYSIOLOGICAL STUDIES ONLY)
Product Code: JOQ
Device Class: 2
Regulation Number: 870.1750
Medical Specialty: Cardiovascular
Registered Establishment Name: FISCHER MEDICAL
Registered Establishment Number: 3006188092
Premarket Submission Number: K991293
Owner/Operator: FISCHER MEDICAL
Owner/Operator Number: 9099682
Establishment Operations: Manufacturer; Remanufacturer
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