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510(k) K893216

Device
RMI ULTRASOUND DOPPLER PHANTOM SYSTEM
Applicant
RADIATION MEASUREMENTS, INC.
510(k) number
K893216
Product code
GXX  
Decision
Substantially Equivalent (SESE)
Decision date
1989-09-05
Date received
1989-04-27
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
MARIE JENNARO
Address
P.O. Box 327 7617 Donna Dr. Middleton WI US 53562 53562

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
K844120ULTRASONIC SCANNER CALIBRATION & TEST OBJECTSEcho Ultrasound1985-01-23
K844247ULTRASONIC SCANNER CALIBRATION & TEST PHANTOMSTechnicare Corp.1985-01-23

Legacy Summary#

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FDA Review#

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