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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name System, Imaging, Pulsed Echo, Ultrasonic
510(k) Number K921426
Device Name ULTRA PCI
Applicant
Advanced Medical Products, Inc.
4709 Crossroads Park Dr.
Liverpool,  NY  13088
Applicant Contact EARL D MARTIN
Correspondent
Advanced Medical Products, Inc.
4709 Crossroads Park Dr.
Liverpool,  NY  13088
Correspondent Contact EARL D MARTIN
Regulation Number892.1560
Classification Product Code
IYO  
Date Received03/24/1992
Decision Date 10/05/1992
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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