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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 K860537
Device Name THE CELL CARE SYSTEM
Applicant
The Clell Corp.
1503 Nora Dr.
Arlington,  TX  76013
Applicant Contact DON CLEVELAND
Correspondent
The Clell Corp.
1503 Nora Dr.
Arlington,  TX  76013
Correspondent Contact DON CLEVELAND
Regulation Number880.2400
Classification Product Code
KMI  
Date Received02/11/1986
Decision Date 04/17/1986
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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