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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name System, Measurement, Blood-Pressure, Non-Invasive
510(k) Number K003180
Device Name HOMMED OBSERVER, MODEL I
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 Number870.1130
Classification Product Code
DXN  
Date Received10/11/2000
Decision Date 06/28/2001
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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