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510(k) K191313

Device
Unity Subcutaneous Infusion System For Remodulin
Applicant
DEKA Research & Development
510(k) number
K191313
Product code
QJY  
Decision
Substantially Equivalent (SESE)
Decision date
2020-02-21
Date received
2019-05-15
Regulation
880.5725
Classification name
Infusion Pump, Drug Specific, Pharmacy-filled
Medical specialty
General Hospital
Review panel
General Hospital
Device class
2
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
No

Applicant Contact#

Contact
Jason Demers
Address
340 Commercial St. Manchester NH US 03101 03101

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

Other 510(k) Records For Product Code QJY  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K243354Remunity SystemDeka Research & Development Corp.2024-11-27
K240256Remunity SystemDeka Research and Development2024-06-12
K202690Remunity Pump for Remodulin (treprostinil) InjectionDeka Research and Development2020-12-30

Legacy Summary#

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FDA Review#

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