V80 Anesthetic Vaporizer (V80)— 510(k) K240375

Substantially Equivalent

Shenzhen Mindray Bio-Medical Electronics Co., Ltd.

FDA 510(k) clearance K240375 for V80 Anesthetic Vaporizer (V80), Substantially Equivalent on 2024-10-31. Applicant: Shenzhen Mindray Bio-Medical Electronics Co., Ltd..

Clearance details

Applicant: Shenzhen Mindray Bio-Medical Electronics Co., Ltd.
Product code: Code CAD
Advisory panel: Anesthesiology
Date received: 2024-02-07
Decision date: 2024-10-31
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Shenzhen, CN

Download summary PDF View on FDA.gov ↗

Adverse events under product code CAD

product code CAD

Malfunction: 3,275
Total: 3,275

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.