Home / 510(k) Clearances / K180788

510(k) K180788

Gas Module 3 by Shenzhen Mindray Bio-Medical Electronics Co., Ltd. — Product Code BZK

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 24, 2018
Date Received
March 26, 2018
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Spirometer, Monitoring (W/Wo Alarm)
Device Class
Class II
Regulation Number
868.1850
Review Panel
AN
Submission Type

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