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510(k) K150174

Device
EMMA
Applicant
INRANGE SYSTEMS, INC.
510(k) number
K150174
Product code
NZH  
Decision
Substantially Equivalent (SESE)
Decision date
2015-02-26
Date received
2015-01-26
Regulation
880.6315
Classification name
Medication Management System, Remote
Medical specialty
General Hospital
Review panel
General Hospital
Device class
2
Clearance type
Special
Statement or summary
Statement
Third party reviewed
No

Applicant Contact#

Contact
Christopher E Bossi
Address
3316 5th Ave. - Suite 100 Altoona PA US 16602 16602

Source Documents#

510(k) summary PDF not indicated by FDA

Other 510(k) Records For Product Code NZH  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
DEN060002INRANGE REMOTE MEDICATION MANAGEMENT SYSTEMInrange Systems, Inc.2007-06-13

Legacy Summary#

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FDA Review#

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