K242562
- 510(k) number
- K242562
- Device name
- Monitor B105M; Monitor B125M; Monitor B155M; Monitor B105P; Monitor B125P
- Applicant
- Ge Medical Systems Information Technologies, Inc. WI · US
- Product code
- MHX — Monitor, Physiological, Patient(With Arrhythmia Dete
- Decision date
- 2025-07-09
- Date received
- 2024-08-28
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Cardiovascular
510(k) Summary (official FDA PDF): K242562.pdf
Official FDA record: K242562
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.