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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Medication Management System, Remote
510(k) Number K150174
Device Name EMMA
Applicant
Inrange Systems, Inc.
3316 5th Ave. - Suite 100
Altoona,  PA  16602
Applicant Contact Christopher E Bossi
Correspondent
Inrange Systems, Inc.
3316 5th Ave. - Suite 100
Altoona,  PA  16602
Correspondent Contact Christopher E Bossi
Regulation Number880.6315
Classification Product Code
NZH  
Date Received01/26/2015
Decision Date 02/26/2015
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Statement Statement
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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