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510(k) K830876

Device
PREP-CHECK
Applicant
GENERAL DEVICES
510(k) number
K830876
Product code
KRC  
Decision
Substantially Equivalent (SESE)
Decision date
1983-05-18
Date received
1983-03-18
Regulation
870.2370
Classification name
Tester, Electrode, Surface, Electrocardiographic
Medical specialty
Cardiovascular
Review panel
Cardiovascular
Device class
2
Clearance type
Traditional
Third party reviewed
No

Applicant Contact#

Contact
Michael Smith
Address
86 Harriet Ave. Bergenfield NJ US 07621 07621

FDA Registration Numbers#

Source Documents#

510(k) summary PDF not indicated by FDA

Other 510(k) Records For Product Code KRC  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K023713SONOPREP IMPEDANCE DIAGNOSTICS (IDX) SYSTEM, MODEL D1000Sontra Medical, Inc.2004-01-28
K872370BIOMA 3500E.B.S., Inc.1987-12-07
K874155CIRCAMED MONITOR REMOTE START CONDUCTANCE METERCircadian, Inc.1987-11-23
K874327SKIN PREP ANALYZERMarquette Electronics, Inc.1987-11-23
K840358IMPEDANCE/8200 MONITOR-MODEL 8300Aequitron Medical, Inc.1984-10-30
K833619CONDUCTANCE METERCircadian, Inc.1984-01-27
K830823Z VIEW METER MODEL 300Lintronics Industries, Inc.1983-05-18
K813358GERARD MEDICAL ELECTRODE TESTERGerard Medical Enterprises, Inc.1981-12-29
K780501ELECTRODE TESTERMg Medical Electronics1978-05-19
K771014TS-100 TEST SYSTEMDelta Medical Industries1977-06-14

Legacy Summary#

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FDA Review#

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