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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 K925529
Device Name WANDER CARE
Applicant
Care Electronics, Inc.
5741 Arapahoe Rd.
Suite 2a
Boulder,  CO  80303
Applicant Contact THOMAS O MOODY
Correspondent
Care Electronics, Inc.
5741 Arapahoe Rd.
Suite 2a
Boulder,  CO  80303
Correspondent Contact THOMAS O MOODY
Regulation Number880.2400
Classification Product Code
KMI  
Date Received11/02/1992
Decision Date 06/16/1993
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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