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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Oximeter
510(k) Number K260490
Device Name Ninenovo Blood Oxygen Ring (BORMB-01-6,BORMB-01-7,BORMB-01-8,BORMB-01-9,BORMB-01-10,BORMB-01-11,BORMB-01-12,BORMB-01-13,BORMB-01-14)
Applicant
Shenzhen Ninenovo Technology Limited
B801,Sz-Nelb, # 20 Gaoxin S.7th Rd.,Gaoxin District Communit
Yuehai Subdistrict, Nanshan District
Shenzhen,  CN 518055
Applicant Contact Guoxing Wang
Correspondent
Shenzhen Bosstar Consulting Company Limited.
Rm. 1212, Wanjunhui Business Bldg., Xixiang Ave., Bao'An Dis
Shenzhen,  CN 518102
Correspondent Contact Wilson Peng
Regulation Number870.2700
Classification Product Code
DQA  
Date Received02/13/2026
Decision Date 10/02/2026
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Anesthesiology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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