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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)
510(k) Number K250854
Device Name Multi-parameter Patient Monitor (N10); Multi-parameter Patient Monitor (N12); Multi-parameter Patient Monitor (N15); Multi-parameter Patient Monitor (N10MPro); Multi-parameter Patient Monitor (N12MPro); Multi-parameter Patient Monitor (N15MPro)
Applicant
Shenzhen Comen Medical Instruments Co.,Ltd
Floor 10, Floor 11 And Sec C Of Floor 12 Of Bldg. 1a & Floor
Of Bldg. 2, Fiyta Timepiece Bldg, Nanhuan Ave. Matian Sub-Di
Shenzhen,  CN 518106
Applicant Contact Charlotte Lin
Correspondent
Shenzhen Comen Medical Instruments Co.,Ltd
Floor 10, Floor 11 And Sec C Of Floor 12 Of Bldg. 1a & Floor
Of Bldg. 2, Fiyta Timepiece Bldg, Nanhuan Ave. Matian Sub-Di
Shenzhen,  CN 518106
Correspondent Contact Charlotte Lin
Regulation Number870.1025
Classification Product Code
MHX  
Date Received03/21/2025
Decision Date 12/17/2025
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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