FDA.report

510(k) K242693

Device
DEKA Infusion System, DEKA Administration Set
Applicant
Deka Research and Development Corporation
510(k) number
K242693
Product code
LDR
Decision
Substantially Equivalent (SESE)
Decision date
2024-10-07
Date received
2024-09-09
Regulation
880.5725
Classification name
Controller, Infusion, Intravascular, Electronic
Medical specialty
General Hospital
Review panel
General Hospital
Device class
2
Clearance type
Special
Statement or summary
Summary
Third party reviewed
No

Related Records

Applicant Contact

Contact
Paul Smolenski
Address
340 Commercial St. Manchester NH US 03101 03101

FDA Registration Numbers

Source Documents

510(k) summary PDF

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