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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 K895253
Device Name PNEUMOCHECK W/PRINTER/CHARGER AND ACCESSORIES
Applicant
WELCH ALLYN, INC.
4341 STATE ST. RD.
P.O. BOX 220
SKANEATELES FALLS,  NY  13153 -0220
Applicant Contact JOHN WATKINS
Correspondent
WELCH ALLYN, INC.
4341 STATE ST. RD.
P.O. BOX 220
SKANEATELES FALLS,  NY  13153 -0220
Correspondent Contact JOHN WATKINS
Regulation Number868.1840
Classification Product Code
BZG  
Date Received08/21/1989
Decision Date 11/02/1989
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Type Traditional
Reviewed by Third Party No
Combination Product No
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