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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 K240092
Device Name Pulse Oximeter (YM101, YM102, YM103, YM104, YM201, YM301, YM202, YM302, YM111, YM112, YM113, YM114, YM211, YM212, YM314, YM601, YM602, YM401, YM402, YM403, YM501, YM502, YM503 and YM504)
Applicant
Shenzhen Yimi Life Technology Co., Ltd.
302 Bldg. C, Youlitong Technology Industrial Plant, #56
Qingsong Rd., Laokeng Community, Longtian St.
Shenzhen,  CN 518118
Applicant Contact Peng Shande
Correspondent
Shenzhen Yimi Life Technology Co., Ltd.
302 Bldg. C, Youlitong Technology Industrial Plant, #56
Qingsong Rd., Laokeng Community, Longtian St.
Shenzhen,  CN 518118
Correspondent Contact Peng Shande
Regulation Number870.2700
Classification Product Code
DQA  
Date Received01/12/2024
Decision Date 10/25/2024
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Anesthesiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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