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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 K233440
Device Name Avalon CL Fetal & Maternal (F&M) Pod (866488), Avalon CL Fetal & Maternal (F&M) Patch (989803196341)
Applicant
Philips Medizin Systeme Boeblingen GmbH
Hewlett-Packard St. 2
Boeblingen,  DE
Applicant Contact Trang Adams
Correspondent
Philips Medizin Systeme Boeblingen GmbH
222 Jacobs St.
Cambridge,  MA  02141
Correspondent Contact Peng Cui
Regulation Number884.2740
Classification Product Code
HGM  
Subsequent Product Codes
DRX   OSP  
Date Received10/18/2023
Decision Date 07/02/2024
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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