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510(k) K143580

PeriCoach by Analytica, Ltd. — Product Code HIR

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 18, 2015
Date Received
December 18, 2014
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Perineometer
Device Class
Class II
Regulation Number
884.1425
Review Panel
GU
Submission Type

Other clearances by Analytica, Ltd.

  • K160758 — PeriCoach OTC (July 11, 2016)

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