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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., N.W.
WASHINGTON,  DC  20004
Applicant Contact & HARTSON
Correspondent
PORTER INSTRUMENT CO., INC.
COLUMBIA SQUARE
555 THIRTEENTH ST., N.W.
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
Recalls CDRH Recalls
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