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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Transmitters And Receivers, Physiological Signal, Radiofrequency
510(k) Number K242018
Device Name UbiqVue™ 2A Multi-parameter System (UX2550)
Applicant
LifeSignals, Inc.
426 S Hillview Dr.
Milpitas,  CA  95035
Applicant Contact Saravanan Balasubramanian
Correspondent
LifeSignals, Inc.
426 S Hillview Dr.
Milpitas,  CA  95035
Correspondent Contact Saravanan Balasubramanian
Regulation Number870.2910
Classification Product Code
DRG  
Subsequent Product Codes
DQA   FLL   MHX  
Date Received07/10/2024
Decision Date 11/12/2024
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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