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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 K854950
Device Name BED PATIENT MONITOR
Applicant
Clearview Electronics Corp.
P.O. Box 326 (31 Phoenix Ave)
Newark,  DE  19715
Applicant Contact W. C SWARTOUT
Correspondent
Clearview Electronics Corp.
P.O. Box 326 (31 Phoenix Ave)
Newark,  DE  19715
Correspondent Contact W. C SWARTOUT
Regulation Number880.2400
Classification Product Code
KMI  
Date Received12/10/1985
Decision Date 03/25/1986
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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