Monitor B125, Monitor B105— 510(k) K171580

Clearance details

Applicant

Ge Medical Systems (China) Co., Ltd.

Product code

Code MHX

Device class

Class 2

Regulation

21 CFR 870.1025

Advisory panel

Cardiovascular

Date received

2017-05-31

Decision date

2017-11-01

Decision

Substantially Equivalent

Clearance type

Traditional

Location

Wuxi, CN

• K260656 — Carescape ONE +6 more2026-09-01
• K260343 — Carescape Canvas 1000; Carescape Canvas Smart Display2026-08-28
• K260579 — Infinity® Acute Care System (IACS) VG8.12026-08-20
• K251508 — Telemetry Monitor (iT30, iT50)2026-08-06
• K253277 — Monitor B105M; Monitor B125M; Monitor B155M; Monitor B105P; Monitor B125P2026-07-24

• K151063 — Monitor B402015-12-15
• K142288 — MAC 800 Resting ECG Analysis System2014-12-03
• K133576 — MONITOR B402014-02-21
• K130584 — MONITOR B402013-06-26
• K122253 — PROCARE MONITOR B202013-03-22

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 →

• Z-0587-2019 — B105/125 Patient Monitor. The device is a portable multiparameter unit to be used for monitoring and recording of, and to generate alarms for, multiple physiological parameters of adult, pediatric, and neonatal patients in a hospital environment and during intra-hospital transport.Class II·Ongoing·GE Healthcare, LLC·20180911

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K171580.