M5 DIAGNOSTIC ULTRASOUND SYSTEM— 510(k) K080640

Clearance details

Applicant

Shenzhen Mindray Bio-Medical Electronics Co., Ltd.

Product code

Code IYN

Device class

Class 2

Regulation

21 CFR 892.1550

Advisory panel

Radiology

Date received

2008-03-06

Decision date

2008-03-21

Decision

Substantially Equivalent

Clearance type

Traditional

Location

Great Neck, NY, US

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Death

25

Injury

163

Malfunction

1,538

Other

4

Total

1,730

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 →