K252840
- 510(k) number
- K252840
- Device name
- M12 Telemetry System
- Applicant
- Global Instrumentation, LLC NY · US
- Product code
- MHX — Monitor, Physiological, Patient(With Arrhythmia Dete
- Decision date
- 2026-05-29
- Date received
- 2025-09-05
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Cardiovascular
PDFDownload 510(k) SummaryArchived here · 2.8 MB · U.S. public domain
Also available from FDA: K252840.pdf
Official FDA record: K252840
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.