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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Flowmeter, Nonback-Pressure Compensated, Bourdon Gauge
510(k) Number K934945
Device Name FLOWMETER NIPPLE ADAPTOR
Applicant
CARDIO-SEARCH LTD.
170 OLD GUELPH ROAD
DUNDAS, ONT.L9H 5Y2, CANADA,  CA
Correspondent
CARDIO-SEARCH LTD.
170 OLD GUELPH ROAD
DUNDAS, ONT.L9H 5Y2, CANADA,  CA
Regulation Number868.2300
Classification Product Code
CCN  
Date Received10/13/1993
Decision Date 11/17/1993
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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