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U.S. Department of Health and Human Services

Establishment Registration & Device Listing
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Proprietary Name: M1562B Reusable abdominal/leg belt- 50mm X 1.3M; M2208A Disposable abdominal belts,100/cs; M4601A Reusable Leg Belt- 32mm X 15M; M4602A Reusable Abdominal Belt- 60mm Wd,1.3M Lg; M4603A Reusable Abdominal Belt- 60mm Wd, 15M LG
Classification Name: SYSTEM, MONITORING, PERINATAL
Product Code: HGM
Device Class: 2
Regulation Number: 884.2740
Medical Specialty: Obstetrics/Gynecology
Registered Establishment Name: Philips North America LLC
Registered Establishment Number: 1218950
Premarket Submission Number: K023931
Owner/Operator: Philips Medical Systems International BV
Owner/Operator Number: 1217116
Establishment Operations: Specification Developer
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