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510(k) K844247

Device
ULTRASONIC SCANNER CALIBRATION & TEST PHANTOMS
Applicant
TECHNICARE CORP.
510(k) number
K844247
Product code
GXX  
Decision
Substantially Equivalent (SESE)
Decision date
1985-01-23
Date received
1984-11-01
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
DAVID A ENSOR
Address
90 Inverness Cir. E. Englewood CO US 80112 80112

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
K844120ULTRASONIC SCANNER CALIBRATION & TEST OBJECTSEcho Ultrasound1985-01-23

Legacy Summary#

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FDA Review#

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