510(k) K220107— Mindray SV600 Ventilator, Mindray SV800 Ventilator

Substantially Equivalent

Shenzhen Mindray Bio-Medical Electronics Co., Ltd.

Clearance details

Applicant: Shenzhen Mindray Bio-Medical Electronics Co., Ltd.
Product code: Code CBK
Advisory panel: Anesthesiology
Date received: 2022-01-12
Decision date: 2023-06-16
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Shenzhen, CN

Adverse events under product code CBK

product code CBK

Death: 736
Injury: 3,628
Malfunction: 98,786
Other: 4
Total: 103,154

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.