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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Detector And Alarm, Arrhythmia
510(k) Number K052160
Device Name ACUITY CENTRAL STATION, MODEL 020XXXXX (NOTE: XXXXX = VARIOUS CONFIG.)
Applicant
Welch Allyn, Inc.
4341 State St. Rd.
Skaneateles Falls,  NY  13153
Applicant Contact JOHN E SAWYER
Correspondent
Welch Allyn, Inc.
4341 State St. Rd.
Skaneateles Falls,  NY  13153
Correspondent Contact JOHN E SAWYER
Regulation Number870.1025
Classification Product Code
DSI  
Date Received08/09/2005
Decision Date 12/16/2005
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Abbreviated
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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