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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name monitor, breathing frequency
510(k) Number K051779
Device Name ANDROFLOW - RESPIRATORY RATE MONITOR
Applicant
ANDROMED, INC.
4610 CHEMIN DU BOIS-FRANC
SAINT LAURENT, QUEBEC,  CA H4S 1A7
Applicant Contact GEORGE PAPAGIANNIS
Correspondent
ANDROMED, INC.
4610 CHEMIN DU BOIS-FRANC
SAINT LAURENT, QUEBEC,  CA H4S 1A7
Correspondent Contact GEORGE PAPAGIANNIS
Regulation Number868.2375
Classification Product Code
BZQ  
Date Received07/01/2005
Decision Date 09/30/2005
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Statement Statement
Type Abbreviated
Reviewed by Third Party No
Combination Product No
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