510(k) K212752

Med-link Pulse Oximeter by Shenzhen Med-Link Electronics Tech Co., Ltd. — Product Code DQA

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 20, 2022
Date Received
August 30, 2021
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