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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name ventilator, external body, negative pressure, adult (cuirass)
510(k) Number K863300
Device Name Q101 DIAGNOSTIC SPIROMETER
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 Number868.5935
Classification Product Code
BYT  
Date Received08/25/1986
Decision Date 11/13/1986
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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