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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 K252655
Device Name Pulse Oximeter (PO-A2AO, PO-A2AT, PO-A3AO, PO-H1AO, PO-B1AO, PO-C5AO, PO-C5AT, PO-C6AO, PO-C6AT)
Applicant
Shenzhen Imdk Medical Technology Co., Ltd.
904, 9f, Guangming Tianan Cloud Park Bldg, 255 Zhenmei Rd.
Zhenmei Community, Xinhu St., Guangming District
Shenzhen,  CN 518107
Applicant Contact Yuan Xia
Correspondent
Shanghai Truthful Information Technology Co., Ltd.
Rm. 1801, # 161 E. Lu Jiazui Rd., Pudong
Shanghai,  CN 200120
Correspondent Contact Boyle Wang
Regulation Number870.2700
Classification Product Code
DQA  
Date Received08/22/2025
Decision Date 05/11/2026
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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