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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms)
510(k) Number K001265
Device Name WELCH ALLYN INSTRUMENT INTERFACE MODULE
Applicant
Welch Allyn, Inc.
4341 State St. Rd.
P.O. Box 220
Skaneateles Falls,  NY  13153
Applicant Contact DAVID KLEMENTOWSKI
Correspondent
Welch Allyn, Inc.
4341 State St. Rd.
P.O. Box 220
Skaneateles Falls,  NY  13153
Correspondent Contact DAVID KLEMENTOWSKI
Regulation Number870.2300
Classification Product Code
MWI  
Date Received04/19/2000
Decision Date 07/13/2000
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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