Mural Perinatal Surveillance— 510(k) K220732
Substantially EquivalentGe Medical Systems Information Technologies, Inc.
FDA 510(k) clearance K220732 for Mural Perinatal Surveillance, Substantially Equivalent on 2022-06-23. Applicant: Ge Medical Systems Information Technologies, Inc.. Device class: 2.
Clearance details
- Applicant
- Ge Medical Systems Information Technologies, Inc.
- Product code
- Code HGM
- Device class
- Class 2
- Regulation
- 21 CFR 884.2740
- Advisory panel
- Obstetrics/Gynecology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Wauwatosa, WI, US
Recent devices under product code HGM
view allMore clearances from Ge Medical Systems Information Technologies, Inc.
view all- K253277 — Monitor B105M; Monitor B125M; Monitor B155M; Monitor B105P; Monitor B125P
- 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
Adverse events under product code HGM
product code HGM- Death
- 35
- Malfunction
- 478
- Total
- 513
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 →
Data sourced from openFDA. This site is unofficial and independent of the FDA.