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510(k) K911166

Device
DIAGNOSTIC ULTRASOUND/URO-GYN UD 511
Applicant
DIAGNOSTIC ULTRASOUND CORP.
510(k) number
K911166
Product code
LST  
Decision
Substantially Equivalent (SESE)
Decision date
1991-08-15
Date received
1991-03-15
Regulation
510(k) Premarket Notification
Classification name
Device, Erectile Dysfunction
Medical specialty
510(k) Premarket Notification // Quick Links: Skip To Main Page Content Skip To Search Skip To Topics Menu Skip To Common Links U.S. Food & Drug Administration   Follow FDA En Español Search FDA   Home Food Drugs Medical Devices
Review panel
Gastroenterology/Urology
Device class
2
Clearance type
Traditional
Third party reviewed
No

Applicant Contact#

Contact
GERALD MCMORROW
Address
P.O. Box 0789 Kirkland WA US 98083 98083

FDA Registration Numbers#

Source Documents#

510(k) summary PDF not indicated by FDA

Legacy Summary#

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FDA Review#

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