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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Oximeter
510(k) Number K021246
Device Name SENSAID, MODELS# RC-NVA30-10; RC-CS140-10; RC-BC150-3
Applicant
SENSIDYNE, INC.
16333 BAY VISTA DR.
CLEARWATER,  FL  33760
Applicant Contact GEORGE MASON
Correspondent
SENSIDYNE, INC.
16333 BAY VISTA DR.
CLEARWATER,  FL  33760
Correspondent Contact GEORGE MASON
Regulation Number870.2700
Classification Product Code
DQA  
Date Received04/19/2002
Decision Date 05/13/2002
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Anesthesiology
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
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