MONITOR B40— 510(k) K133576
Substantially EquivalentGe Medical Systems China Co., Ltd.
FDA 510(k) clearance K133576 for MONITOR B40, Substantially Equivalent on 2014-02-21. Applicant: Ge Medical Systems China Co., Ltd.. Device class: 2.
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
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Location
- Milwaukee, WI, US
Recent devices under product code MHX
view allMore clearances from Ge Medical Systems China Co., Ltd.
view allAdverse 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 K133576
K-number listed on FDA's recall record- Z-0760-2020 — Airway Gas Option N-CAiO
- Z-0584-2019 — PROCARE B40 Patient Monitor, V1; and B40 Patient Monitor, V2, V2.1, and V3. The PROCARE Monitor B40 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.
- Z-2617-2014 — CARESCAPE Respiratory Modules E-sCO, E-sCOV, E-sCAiO, E-sCAiOV, E-sCAiOE, E-sCAiOVE; the Airway Gas Option N-CAiO and respective service exchange units. The affected modules could be in use with any of the following GE host devices: -CARESCAPE respiratory modules with CARESCAPE Monitors B850, B650 and B450, S/5 modular monitors, Avance CS2 and Aisys CS2 Anesthesia Carestations, B40 Patient Monitor -Airway Gas Option N-CAiO modules with B40 Patient Monitor
Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K133576.
Data sourced from openFDA. This site is unofficial and independent of the FDA.