Atlas FDA

M12 Telemetry System

FDA 510(k) clearance K252840 · decided 2026-05-29

Clearance details

K-number
K252840
Device name
M12 Telemetry System
Applicant
Global Instrumentation, LLC
Decision
Substantially Equivalent
Date received
2025-09-05
Decision date
2026-05-29
Days to decision
266 days
Clearance type
Traditional
Product code
MHX
Device class
2
Regulation number
870.1025
Medical specialty
Cardiovascular
Advisory committee
Cardiovascular
Location
East Syracuse, NY, US
Third-party review
No
Expedited review
No

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Recalls involving this device

No recalls on record reference this clearance.