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U.S. Department of Health and Human Services

Establishment Registration & Device Listing

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Proprietary Name: STAN S31 FETAL HEART MONITOR
Classification Name: ANALYZER, DATA, OBSTETRIC
Product Code: HEO
Device Class: 3
Regulation Number: 884.2050
Medical Specialty: Obstetrics/Gynecology
Registered Establishment Name: AXCESOR, INC.
Registered Establishment Number: 2134752
Owner/Operator: AXCESOR, INC.
Owner/Operator Number: 9012066
Establishment Operations: Contract Manufacturer
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