M12 Telemetry System— 510(k) K252840
Substantially EquivalentGlobal Instrumentation, LLC
FDA 510(k) clearance K252840 for M12 Telemetry System, Substantially Equivalent on 2026-05-29. Applicant: Global Instrumentation, LLC. Device class: 2.
Summary
Global Instrumentation's M12 Telemetry System is filed under MHX, physiological patient monitors with arrhythmia detection or alarms.
Class II, 21 CFR 870.1025. Cardiovascular is both the classification panel and the review panel. It came in as a Traditional 510(k).
The company filed from East Syracuse, New York. The decision came 266 calendar days after receipt (September 5, 2025 to May 29, 2026).
Clearance details
- Applicant
- Global Instrumentation, LLC
- Product code
- Product code MHX
- Device class
- Class 2
- Regulation
- 21 CFR 870.1025
- Advisory panel
- Cardiovascular
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- East Syracuse, NY, US
Recent devices under product code MHX
view allMore clearances from Global Instrumentation, LLC
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 →
Data sourced from openFDA. This site is unofficial and independent of the FDA.