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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Monitor, Bed Patient
510(k) Number K871203
Device Name BED PATIENT PRESENCE MONITOR
Applicant
HUMAN TECHNOLOGIES, INC.
1325 SNELL ISLE BLVD N.E.
ST. PETERSBURG,  FL  33704
Applicant Contact MICHAEL HAZEL
Correspondent
HUMAN TECHNOLOGIES, INC.
1325 SNELL ISLE BLVD N.E.
ST. PETERSBURG,  FL  33704
Correspondent Contact MICHAEL HAZEL
Regulation Number880.2400
Classification Product Code
KMI  
Date Received03/25/1987
Decision Date 05/26/1987
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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