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510(k) K844120

Device
ULTRASONIC SCANNER CALIBRATION & TEST OBJECTS
Applicant
ECHO ULTRASOUND
510(k) number
K844120
Product code
GXX  
Decision
Substantially Equivalent (SESE)
Decision date
1985-01-23
Date received
1984-10-23
Regulation
882.1925
Classification name
Block, Test, Ultrasonic Scanner Calibration
Medical specialty
Neurology
Review panel
Neurology
Device class
1
Clearance type
Traditional
Third party reviewed
No

Applicant Contact#

Contact
RUSSELL W WOODS
Address
Post Office Box 552 Lewistown PA US 17044 17044

Source Documents#

510(k) summary PDF not indicated by FDA

Other 510(k) Records For Product Code GXX  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K893216RMI ULTRASOUND DOPPLER PHANTOM SYSTEMRadiation Measurements, Inc.1989-09-05
K844247ULTRASONIC SCANNER CALIBRATION & TEST PHANTOMSTechnicare Corp.1985-01-23

Legacy Summary#

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FDA Review#

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