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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 K062724
Device Name ACCUPULSE PULSE OXIMETER
Applicant
Eagle Medical Equipment Co.
537 N. Spencer
Mesa,  AZ  85203
Applicant Contact JAMES A DUNNING
Correspondent
Eagle Medical Equipment Co.
537 N. Spencer
Mesa,  AZ  85203
Correspondent Contact JAMES A DUNNING
Regulation Number870.2700
Classification Product Code
DQA  
Date Received09/12/2006
Decision Date 05/11/2007
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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