A7 Anesthesia System— 510(k) K142552

Substantially Equivalent

Shenzhen Mindray Bio-Medical Electronics Co., Ltd.

FDA 510(k) clearance K142552 for A7 Anesthesia System, Substantially Equivalent on 2015-01-23. Applicant: 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: 2014-09-10
Decision date: 2015-01-23
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Shenzhen, CN

Download summary PDF View on FDA.gov ↗

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.