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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 K090138
Device Name MOBILECARE MONITOR, MODEL 2100
Applicant
Aframe Digital, Inc.
15637 Fox Cove Circle
Mosely,  VA  23120
Applicant Contact DARREN REEVES
Correspondent
Aframe Digital, Inc.
15637 Fox Cove Circle
Mosely,  VA  23120
Correspondent Contact DARREN REEVES
Regulation Number880.2400
Classification Product Code
KMI  
Date Received01/21/2009
Decision Date 04/24/2009
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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