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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Interventional Fluoroscopic X-Ray System
510(k) Number K011292
Device Name ZIEHM VISION
Applicant
ZIEHM INTERNATIONAL, INC.
4181 LATHAM ST.
RIVERSIDE,  CA  92501
Applicant Contact LANELL SAMANIEGO
Correspondent
ZIEHM INTERNATIONAL, INC.
4181 LATHAM ST.
RIVERSIDE,  CA  92501
Correspondent Contact LANELL SAMANIEGO
Regulation Number892.1650
Classification Product Code
OWB  
Subsequent Product Codes
JAA   OXO  
Date Received04/30/2001
Decision Date 06/20/2001
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Type Traditional
Reviewed by Third Party No
Combination Product No
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