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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Flowmeter, Tube, Thorpe, Back-Pressure Compensated
510(k) Number K884973
Device Name FR6000 FLOWMETER
Applicant
Key Instruments
250 Andrews Rd.
Trevose,  PA  19053
Applicant Contact DONALD C FRICK
Correspondent
Key Instruments
250 Andrews Rd.
Trevose,  PA  19053
Correspondent Contact DONALD C FRICK
Regulation Number868.2340
Classification Product Code
CAX  
Date Received11/30/1988
Decision Date 01/17/1989
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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