510(k) K201957

A8, A9 Anesthesia System by Shenzhen Mindray Bio-Medical Electronics Co., Ltd. — Product Code BSZ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 26, 2021
Date Received
July 14, 2020
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Gas-Machine, Anesthesia
Device Class
Class II
Regulation Number
868.5160
Review Panel
AN
Submission Type