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U.S. Department of Health and Human Services

Establishment Registration & Device Listing
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Proprietary Name: NICOLETONE SYSTEM V32 AMPLIFIER
Classification Name: FULL-MONTAGE STANDARD ELECTROENCEPHALOGRAPH
Product Code: GWQ
Device Class: 2
Regulation Number: 882.1400
Medical Specialty: Neurology
Registered Establishment Name: Natus Neurology Incorporated
Registered Establishment Number: 3010611950
Premarket Submission Number: K061908
Owner/Operator: Natus Medical Incorporated
Owner/Operator Number: 9004873
Establishment Operations: Specification Developer
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