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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 K883390
Device Name PMD SYSTEM-20
Applicant
Datatek, Inc.
333 Southfield Rd.
Shreveport,  LA  71105
Applicant Contact RAYMOND G TAYLOR
Correspondent
Datatek, Inc.
333 Southfield Rd.
Shreveport,  LA  71105
Correspondent Contact RAYMOND G TAYLOR
Regulation Number880.2400
Classification Product Code
KMI  
Date Received08/09/1988
Decision Date 10/25/1988
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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