FDA.report

510(k) K934543

Device
Universal Controller, Model 100
Applicant
METAMED, INC.
510(k) number
K934543
Product code
LDR
Decision
Substantially Equivalent (SESE)
Decision date
1994-03-29
Date received
1993-09-16
Regulation
880.5725
Classification name
Controller, Infusion, Intravascular, Electronic
Medical specialty
General Hospital
Review panel
General Hospital
Device class
2
Clearance type
Traditional
Statement or summary
Statement
Third party reviewed
No

Related Records

Applicant Contact

Contact
HOWARD EVERHART
Address
5937 Balboa Ave., Suite 103 San Diego CA US 92111 92111

FDA Registration Numbers

Source Documents

510(k) summary PDF not indicated by FDA

Other 510(k) Records For Product Code LDR

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
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
K882167IVY COMMANDER, MODEL 600Ivy Medical, Inc.1988-09-23