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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 Rd.
Dundas, Ont.L9h 5y2, Canada,  CA
Correspondent
Cardio-Search , Ltd.
170 Old Guelph Rd.
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
Predetermined Change
Control Plan Authorized		 No
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