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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 K190399
Device Name Beddr 200 System
Applicant
Hancock Medical, Inc.
897 Independence Ave., #3a
Mountain View,  CA  94043
Applicant Contact Tom Goff
Correspondent
Hancock Medical, Inc.
897 Independence Ave., #3a
Mountain View,  CA  94043
Correspondent Contact Tom Goff
Regulation Number870.2700
Classification Product Code
DQA  
Date Received02/19/2019
Decision Date 08/05/2019
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Anesthesiology
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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