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510(k) K910212

Device
COLOR DOPPLER OPTION TO AI 5200 DIAG ULTRASO SYST
Applicant
ACOUSTIC IMAGING TECHNOLOGIES CORP.
510(k) number
K910212
Product code
JYO  
Decision
Substantially Equivalent (SESE)
Decision date
1991-07-11
Date received
1991-01-15
Regulation
874.4420
Classification name
Knife, Ear
Medical specialty
Ear Nose & Throat
Review panel
Radiology
Device class
1
Clearance type
Traditional
Third party reviewed
No

Applicant Contact#

Contact
LORI CADWELL
Address
10027 S. 15st St. Phoenix AZ US 85044 85044

FDA Registration Numbers#

Source Documents#

510(k) summary PDF not indicated by FDA

Other 510(k) Records For Product Code JYO  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K841006EAR KNIFE-VARIOUSPremier Dental Products Co.1984-05-30
K840764EAR KNIVESSharpoint, Inc.1984-05-21
K833602ROLLER KNIFE-TRANSVERSE -SAGITTALMicrotek Medical, Inc.1984-01-03
K823911KNIFE BLADE TIPTreace Medical, Inc.1983-01-21
K772372ROLLER KNIFEEdward Weck, Inc.1978-01-17
K772384MYRINGOTOMY KNIFEEdward Weck, Inc.1978-01-17

Legacy Summary#

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FDA Review#

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