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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 K004044
Device Name HOMMED SENTRY III PATIENT MONITOR SYSTEM
Applicant
Hommed, LLC
2018 N. Durham Dr.
Houston,  TX  77008
Applicant Contact TOMMIE J MORGAN
Correspondent
Hommed, LLC
2018 N. Durham Dr.
Houston,  TX  77008
Correspondent Contact TOMMIE J MORGAN
Regulation Number870.2700
Classification Product Code
DQA  
Date Received12/29/2000
Decision Date 03/02/2001
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Anesthesiology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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