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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name oximeter
510(k) Number K091787
Device Name MODEL 6000 TWO PARAMETER BEDSIDE MONITOR
Applicant
IVY BIOMEDICAL SYSTEMS, INC.
11 BUSINESS PARK DR.
BRANFORD,  CT  06405
Applicant Contact JENNIFER LAINE
Correspondent
IVY BIOMEDICAL SYSTEMS, INC.
11 BUSINESS PARK DR.
BRANFORD,  CT  06405
Correspondent Contact JENNIFER LAINE
Regulation Number870.2700
Classification Product Code
DQA  
Subsequent Product Code
CCK  
Date Received06/17/2009
Decision Date 10/09/2009
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Anesthesiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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