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U.S. Department of Health and Human Services

Establishment Registration & Device Listing

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Proprietary Name: Fetal Monitor Model F2 and F3
Classification Name: TRANSDUCER, ULTRASONIC, OBSTETRIC
Product Code: HGL
Device Class: 2
Regulation Number: 884.2960
Medical Specialty: Obstetrics/Gynecology
Registered Establishment Name: EDAN INSTRUMENTS, INC.
Registered Establishment Number: 3003971136
Owner/Operator: EDAN INSTRUMENTS, INC.
Owner/Operator Number: 9055347
Establishment Operations: Foreign Exporter; Manufacturer
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