510(k) K240092

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) by Shenzhen Yimi Life Technology Co., Ltd. — Product Code DQA

K240092 is an FDA 510(k) premarket notification submitted by Shenzhen Yimi Life Technology Co., Ltd. for the device "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)". The FDA issued a decision of Substantially Equivalent on October 25, 2024. The device falls under product code DQA (Oximeter), a Class II device regulated under 21 CFR 870.2700.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 25, 2024
Date Received
January 12, 2024
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Oximeter
Device Class
Class II
Regulation Number
870.2700
Review Panel
AN
Submission Type