510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K201957Substantially Equivalent

A8, A9 Anesthesia System

Shenzhen Mindray Bio-Medical Electronics Co.,LTD, Shenzhen, CN / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K201957 is the FDA 510(k) clearance record for A8, A9 Anesthesia System, a class II device, cleared for Shenzhen Mindray Bio-Medical Electronics Co., Ltd. on under FDA product code BSZ (Gas-Machine, Anesthesia). FDA records list 160 510(k) clearances for Shenzhen Mindray Bio-Medical Electronics Co., Ltd., from to . As of , FDA records show 6 recalls naming K201957.

Clearance record

Decision date
Received
(255 days to decision)
Product code
BSZ Gas-Machine, Anesthesia
Regulation
21 CFR 868.5160
Device class
Class II
Review panel
Anesthesiology
Applicant
Shenzhen Mindray Bio-Medical Electronics Co., Ltd. Mindray Bldg., Keji 12th Rd. S., Hi-Tech Industrial Park, Na, Shenzhen, CN
510(k) summary
Summary PDF
Third party review
No

Clearances, product code BSZ

Trailing 12 months
2 clearances under product code BSZ in the twelve months to October 2026, May 2026 the highest month at 1.
Show the numbers
Monthly 510(k) clearances under FDA product code BSZ, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20261
June 20261
July 20260
August 20260
September 20260
October 20260