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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 K012706
Device Name IM2001 PULSE OXIMETER
Applicant
Imagyn Medical Technologies, Inc.
1730 Pennsylvania Ave., NW
Washington,  DC  20006
Applicant Contact SANDRA COHEN KALTER
Correspondent
Imagyn Medical Technologies, Inc.
1730 Pennsylvania Ave., NW
Washington,  DC  20006
Correspondent Contact SANDRA COHEN KALTER
Regulation Number870.2700
Classification Product Code
DQA  
Date Received08/14/2001
Decision Date 03/07/2003
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Anesthesiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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