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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name electrocardiograph, ambulatory (without analysis)
510(k) Number K211651
Device Name Eclipse PRO
Spacelabs Healthcare Ltd.
Unit B, Foxholes Centre, John Tate Road
Hertford,  GB SG13 7DT
Applicant Contact Roger Moldon
Speed To Market, Inc.
PO Box 3018
Nederland,  CO  80466
Correspondent Contact Thomas Kroenke
Regulation Number870.2800
Classification Product Code
Date Received05/28/2021
Decision Date 11/22/2021
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No