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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name oximeter
510(k) Number K001308
Device Name MODIFICATION TO ZYMED TELEMETRY SYSTEM, MODEL EASIVIEW
Original Applicant
AGILENT TECHNOLOGIES
1201 "b" n. rice ave.
oxnard,  CA  93030
Original Contact gretel lumley
Regulation Number870.2700
Classification Product Code
DQA  
Date Received04/25/2000
Decision Date 05/17/2000
Decision substantially equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
summary summary
Type Special
Reviewed by Third Party No
Combination Product No
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