K182075

Substantially Equivalent

BeneVision N Series Patient Monitors (Including BeneVision N12, BeneVision N15, BeneVision N17, BeneVision N19. BeneVision N22, BeneVision N1)

Applicant: Shenzhen Mindray Bio-Medical Electronics Co., Ltd.
Product code: MHX
Advisory panel: Cardiovascular
Date received: 2018-08-01
Decision date: 2018-12-10
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Shenzhen, TW

Download summary PDF View on FDA.gov ↗

Adverse events under product code MHX

product code MHX

Death: 580
Injury: 2,441
Malfunction: 12,655
Other: 3
Total: 15,679

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.