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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 Avenue, #3A
Mountain View,  CA  94043
Applicant Contact Tom Goff
Correspondent
Hancock Medical, Inc.
897 Independence Avenue, #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
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