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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Computer, Oxygen-Uptake
510(k) Number K921565
Device Name CARDIOPULMONARY METABOLIC MEASUEMENT CART
Applicant
Quiton Instrument Co.
2121 Terry Ave.
Seattle,  WA  98121
Applicant Contact GREG W SHIPP
Correspondent
Quiton Instrument Co.
2121 Terry Ave.
Seattle,  WA  98121
Correspondent Contact GREG W SHIPP
Regulation Number868.1730
Classification Product Code
BZL  
Date Received04/01/1992
Decision Date 08/11/1994
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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