510(k) K253330— A5 Anesthesia System (A5); A7 Anesthesia System (A7)

Substantially Equivalent

Shenzhen Mindray Bio-Medical Electronics Co., Ltd.

Clearance details

Applicant: Shenzhen Mindray Bio-Medical Electronics Co., Ltd.
Product code: Code BSZ
Advisory panel: Anesthesiology
Date received: 2025-09-30
Decision date: 2026-06-25
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Shenzhen, CN

Adverse events under product code BSZ

product code BSZ

Death: 23
Injury: 298
Malfunction: 32,987
Total: 33,308

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.