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510(k) K834106

Device
INTRAVENOUS INFUSION CONTROLLER
Applicant
CUTTER LABORATORIES, INC.
510(k) number
K834106
Product code
LDR  
Decision
Substantially Equivalent (SESE)
Decision date
1984-05-30
Date received
1983-11-29
Regulation
880.5725
Classification name
Controller, Infusion, Intravascular, Electronic
Medical specialty
General Hospital
Review panel
General Hospital
Device class
2
Clearance type
Traditional
Third party reviewed
No

Applicant Contact#

Address
4221 Richmond Rd., NW Walker MI US 49534 49534

FDA Registration Numbers#

Source Documents#

510(k) summary PDF not indicated by FDA

Other 510(k) Records For Product Code LDR  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K242693DEKA Infusion System, DEKA Administration SetDeka Research and Development Corporation2024-10-07
K232316DEKA Infusion System, DEKA Administration SetDeka Research and Development2024-03-01
K153760Volumetric Infusion ControllerDEKA Research & Development2016-10-03
K963136PACER MODEL 100 INFUSION CONTROLLERHealth Watch, Inc.1997-10-10
K971865ALEXANDER MANUFACTURING CO. RECHARGEABLE BATTERY PART NUMBER M12/500-3PAlexander Mfg. Co.1997-07-03
K971826ALEXANDER MANUFACTURING CO. RECHARGEABLE BATTERY PART NUMBER M12/500Alexander Mfg. Co.1997-07-03
K934543UNIVERSAL CONTROLLER, MODEL 100Metamed, Inc.1994-03-29
K935236FLOW CONTROLLING EXTENSION SETBlock Medical, Inc.1994-02-24
K905498STAT 2 IV PUMPETTEThe Master Medical Corp.1991-04-16
K905497MASTER FLOW I.V. PUMPETTEThe Master Medical Corp.1991-04-16
K8969073M IV FLOW REGULATOR3M Company1990-02-26
K894111VARI-SETSonex Medical1989-09-28
K894487IVAC(R) VOLUMETRIC CONTROLLER - MODEL 262+Y1989-09-27
K893487LIFECARE 75 CONTROLLERAbbott Laboratories1989-07-28
K884307IVAC(R) VOLUMETRIC CONTROLLER - MODEL 262Y1988-11-01

Legacy Summary#

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FDA Review#

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