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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
Applicant
Spacelabs Healthcare, Ltd.
Unit B, Foxholes Centre
John Tate Rd.
Hertford,  GB SG13 7DT
Applicant Contact Roger Moldon
Correspondent
Speed TO Market, Inc.
P.O. Box 3018
Nederland,  CO  80466
Correspondent Contact Thomas Kroenke
Regulation Number870.2800
Classification Product Code
MWJ  
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
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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