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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 (Without Arrhythmia Detection Or Alarms)
510(k) Number K260438
Device Name Vital Signs Monitor (CLEO2)
Applicant
Infinium Medical, Inc.
12151 62nd St. N. #5
Largo,  FL  33773
Applicant Contact Aydin Bilgutay
Correspondent
Shanghai SUNGO Management Consulting Co., Ltd.
14th Floor, Dongfang Bldg., 1500# Century Ave.
Shanghai,  CN 200122
Correspondent Contact Ivy Wang
Regulation Number870.2300
Classification Product Code
MWI  
Subsequent Product Codes
CCK   DQA   DXN   FLL  
Date Received02/11/2026
Decision Date 08/14/2026
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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