Passport Series Patient Monitors (including Passport 17M, Passport 12M and T1)— 510(k) K143195

Substantially Equivalent

Shenzhen Mindray Bio-Meidcal Electronics Co., Ltd.

FDA 510(k) clearance K143195 for Passport Series Patient Monitors (including Passport 17M, Passport 12M and T1), Substantially Equivalent on 2014-12-22. Applicant: Shenzhen Mindray Bio-Meidcal Electronics Co., Ltd..

Clearance details

Applicant: Shenzhen Mindray Bio-Meidcal Electronics Co., Ltd.
Product code: Code MHX
Advisory panel: Cardiovascular
Date received: 2014-11-06
Decision date: 2014-12-22
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.