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510(k) K882830

Device
INFUSION PUMP
Applicant
PEMLAB CORP.
510(k) number
K882830
Product code
LZF  
Decision
Substantially Equivalent (SESE)
Decision date
1988-12-30
Date received
1988-07-08
Regulation
880.5725
Classification name
Pump, Infusion, Analytical Sampling
Medical specialty
General Hospital
Review panel
General Hospital
Device class
2
Clearance type
Traditional
Third party reviewed
No

Applicant Contact#

Contact
BARNEY PARKER
Address
3770 Tansy St. San Diego CA US 92121 92121

FDA Registration Numbers#

Source Documents#

510(k) summary PDF not indicated by FDA

Other 510(k) Records For Product Code LZF  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K192785OptiScanner® 5000 Glucose Monitoring SystemOptiscan Biomedical Corporation2020-02-05
K162042OptiScanner 5000 Glucose Monitoring SystemOptiscan Biomedical Corp.2017-10-16
K011238RODA (REAL TIME OXYGEN DYNAMICS ANALYSIS) MONITORING SYSTEMMetracor Technologies, Inc.2002-01-08
K951739PUMP/BLOOD CHEMISTRY MONITORVia Medical Corp.1996-02-28
K922997VIA 1-01 INFUSION PUMP/BLOOD CHEM. SYST. -- MOD.Via Medical Corp.1994-01-11
K920438VIA 1-01 INFUSION PUMP BLOOD CHEMISTRY SYSTEMVia Medical Corp.1993-10-22

Legacy Summary#

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FDA Review#

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