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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name System, Monitoring, Perinatal
510(k) Number K241009
Device Name PeriCALM Patterns 3.0
Applicant
Perigen, Inc.
Sderot Nim 2
P.O. Box 110
Rishon Letziyon,  IL 7510002
Applicant Contact Alva Candace
Correspondent
Perigen, Inc.
Sderot Nim 2
P.O. Box 110
Rishon Letziyon,  IL 7510002
Correspondent Contact Alva Candace
Regulation Number884.2740
Classification Product Code
HGM  
Date Received04/12/2024
Decision Date 01/10/2025
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Obstetrics/Gynecology
510k Review Panel Obstetrics/Gynecology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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