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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Spirometer, Diagnostic
510(k) Number K082478
Device Name WELCH ALLYN CARDIOPERFECT WORKSTATION SOFTWARE (CPWS) V 1.62
Applicant
Welch Allyn, Inc.
4341 State St. Rd.
P.O. Box 220
Skaneateles Falls,  NY  13153 -0220
Applicant Contact JOHN SAWYER
Correspondent
Welch Allyn, Inc.
4341 State St. Rd.
P.O. Box 220
Skaneateles Falls,  NY  13153 -0220
Correspondent Contact JOHN SAWYER
Regulation Number868.1840
Classification Product Code
BZG  
Date Received08/28/2008
Decision Date 03/09/2009
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Summary Summary
Type Abbreviated
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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