Monitor B105M, Monitor B125M, Monitor B155M, Monitor B105P, Monitor B125P— 510(k) K213490
Substantially EquivalentGe Medical Systems Information Technologies, Inc.
FDA 510(k) clearance K213490 for Monitor B105M, Monitor B125M, Monitor B155M, Monitor B105P, Monitor B125P, Substantially Equivalent on 2022-04-01. Applicant: Ge Medical Systems Information Technologies, Inc.. Device class: 2.
Clearance details
- Applicant
- Ge Medical Systems Information Technologies, Inc.
- Product code
- Code MHX
- Device class
- Class 2
- Regulation
- 21 CFR 870.1025
- Advisory panel
- Cardiovascular
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Wauwatosa, WI, US
Recent devices under product code MHX
view allMore clearances from Ge Medical Systems Information Technologies, Inc.
view all- K251670 — MAC 7 Resting ECG Analysis System
- K242562 — Monitor B105M; Monitor B125M; Monitor B155M; Monitor B105P; Monitor B125P
- K243540 — Mac-Lab (AltiX AI.i); CardioLab (AltiX AI.i); ComboLab (AltiX AI.i); MLCL Client Software (AltiX AI.i)
- K233810 — Portrait VSM
- K234130 — Portrait Mobile Monitoring Solution consists of: Portrait Central Viewer Application (Portrait CVAXB) Portrait Core Services (Portrait CSSXB) Portrait Clinical Alarming Unit (Portrait CAU01) Portrait Mobile Patient Monitor Hardware (Portrait HUBXB) Portrait Mobile Patient Monitor Software (Portrait HSWXB) Portrait Wearable Pulse Oximetry Sensor (Portrait SpO2 P-SA01) Portrait Wearable Pulse Oximetry Sensor (Portrait SpO2 P-SP01) Portrait Wearable Pulse O
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, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Recalls naming K213490
K-number listed on FDA's recall record- Z-0455-2026 — B105P, B125P, B105M, B125M, B155M Patient Monitors; Model nos. 6160000-002 6160000-003 6160000-004 6160000-005 6160000-101 6160000-102 6160000-103 6160000-104 6160000-105 6160001-063 6160001-064 6160001-065 Monitor, Physiological, Patient (With Arrhythmia Detection or Alarms 3/19/26 updated to add B105P Patient Monitor 6160001-061 B125P Patient Monitor 6160001-062 B105M-C Patient Monitor 6160002-033 B105M-A Patient Monitor 6160000-113 B155M-A Patient Monitor 6160000-115 B125P-B Patient Monitor 6160002-022 B105M-B Patient Monitor 6160002-023 B125M-B Patient Monitor 6160002-024 B105M-OR Patient Monitor 6160000-143 B105M-OR Patient Monitor 6160000-144 B155M-OR Patient Monitor 6160000-145
- Z-0729-2023 — B105P Patient Monitor (with E-module slot option), REF 6160000-001-XXXXXX,
- Z-0730-2023 — B125P Patient Monitor (with E-module slot option), REF 6160000-002
- Z-0731-2023 — B105M Patient Monitor, REF 6160000-003
- Z-0732-2023 — B125M Patient Monitor, REF 6160000-004-XXXXXX
- Z-0733-2023 — B125M Patient Monitor, REF 6160000-005-XXXXXXX
Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K213490.
Data sourced from openFDA. This site is unofficial and independent of the FDA.