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510(k) K150398

EUM 100Pro by Ob Tools, Ltd. — Product Code HGM

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 6, 2015
Date Received
February 18, 2015
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
System, Monitoring, Perinatal
Device Class
Class II
Regulation Number
884.2740
Review Panel
OB
Submission Type

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