FDA.reportPublic FDA data

510(k) K844189

Device
LINEAR SCANNER PROBE ELSCINT LTD. TL-35
Applicant
ELSCINT, INC.
510(k) number
K844189
Product code
IYP  
Decision
Substantially Equivalent (SESE)
Decision date
1985-02-25
Date received
1984-10-30
Regulation
892.1370
Classification name
Phantom, Anthropomorphic, Nuclear
Medical specialty
Radiology
Review panel
Radiology
Device class
1
Clearance type
Traditional
Third party reviewed
No

Applicant Contact#

Contact
ROBERT E KENNEY
Address
775 Nicholas Blvd. Elk Grove Village IL US 60007 60007

FDA Registration Numbers#

Source Documents#

510(k) summary PDF not indicated by FDA

Other 510(k) Records For Product Code IYP  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K921878SCANMATE IIICircadian, Inc.1992-09-11
K812893SUPERFLABMick Radio-Nuclear Instruments, Inc.1981-12-08

Legacy Summary#

Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links Follow FDA En Español Home Food Drugs Medical Devices Radiation-Emitting Products Vaccines, Blood & Biologics Animal & Veterinary Cosmetics Tobacco Products FDA Home Medical Devices Databases

FDA Review#

Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links Follow FDA En Español Home Food Drugs Medical Devices Radiation-Emitting Products Vaccines, Blood & Biologics Animal & Veterinary Cosmetics Tobacco Products FDA Home Medical Devices Databases