K232694
- 510(k) number
- K232694
- Device name
- Central Monitoring System (MFM-CMS)
- Applicant
- Edan Instruments, Inc. CN
- Product code
- MHX — Monitor, Physiological, Patient(With Arrhythmia Dete
- Decision date
- 2024-02-05
- Date received
- 2023-09-05
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Cardiovascular
510(k) Summary (official FDA PDF): K232694.pdf
Official FDA record: K232694
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.