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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name Electrocardiograph
510(k) Number K021171
Device Name Q-STRESS ECHO BED
Applicant
MEDICAL POSITIONING, INC.
21911 ERIE LN.
LAKE FOREST,  CA  92630
Applicant Contact CAROL PATTERSON
Correspondent
MEDICAL POSITIONING, INC.
21911 ERIE LN.
LAKE FOREST,  CA  92630
Correspondent Contact CAROL PATTERSON
Regulation Number870.2340
Classification Product Code
DPS  
Date Received04/12/2002
Decision Date 05/08/2002
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized
No
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