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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name plethysmograph, pressure
510(k) Number K893420
Device Name MASTERLAB PFT AND MASTERLAB BODY BOX
Applicant
QUINTON, INC.
2121 TERRY AVE.
SEATLE,  WA  98121
Applicant Contact RON R DUCK
Correspondent
QUINTON, INC.
2121 TERRY AVE.
SEATLE,  WA  98121
Correspondent Contact RON R DUCK
Regulation Number868.1750
Classification Product Code
CCM  
Date Received04/27/1989
Decision Date 06/23/1989
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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