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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Analyzer, Gas, Oxygen, Gaseous-Phase
510(k) Number K072469
Device Name DIGIFLO CONCENTRATOR ANALYZER
Applicant
DIGIFLO, INC.
6942 96TH AVE. SE
MERCER ISLAND,  WA  98040
Applicant Contact MIKE STERN
Correspondent
DIGIFLO, INC.
6942 96TH AVE. SE
MERCER ISLAND,  WA  98040
Correspondent Contact MIKE STERN
Regulation Number868.1720
Classification Product Code
CCL  
Date Received09/04/2007
Decision Date 01/03/2008
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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