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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Gas-Machine, Anesthesia
510(k) Number K062155
Device Name DIGITAL MXR-D FLOWMETER
Applicant
PORTER INSTRUMENT CO., INC.
49 PLAIN STREET
NORTH ATTLRBORO,  MA  02760
Applicant Contact CYNTHIA J.M. NOLTE
Correspondent
PORTER INSTRUMENT CO., INC.
49 PLAIN STREET
NORTH ATTLRBORO,  MA  02760
Correspondent Contact CYNTHIA J.M. NOLTE
Regulation Number868.5160
Classification Product Code
BSZ  
Date Received07/28/2006
Decision Date 11/09/2006
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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