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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 K923781
Device Name MXR-2000 FLOWMETER
Applicant
Porter Instrument Co., Inc.
Columbia Square
555 Thirteenth St. NW
Washington,  DC  20004
Applicant Contact & HARTSON
Correspondent
Porter Instrument Co., Inc.
Columbia Square
555 Thirteenth St. NW
Washington,  DC  20004
Correspondent Contact & HARTSON
Regulation Number868.2340
Classification Product Code
CAX  
Date Received07/28/1992
Decision Date 06/10/1993
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
Recalls CDRH Recalls
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