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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name System, Measurement, Blood-Pressure, Non-Invasive
510(k) Number K023495
Device Name WELCH ALLYN VITALS SOFTWARE DEVELOPERS KIT (SDK)
Applicant
Welch Allyn, Inc.
4341 State St. Rd.
P.O. Box 220
Skaneateles Falls,  NY  13153 -0220
Applicant Contact DAVID KLEMENTOWSKI
Correspondent
Welch Allyn, Inc.
4341 State St. Rd.
P.O. Box 220
Skaneateles Falls,  NY  13153 -0220
Correspondent Contact DAVID KLEMENTOWSKI
Regulation Number870.1130
Classification Product Code
DXN  
Date Received10/18/2002
Decision Date 10/31/2002
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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