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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 K050018
Device Name TESLAOXYSAT, MODEL EFOXYSATE
Applicant
Mammendorfer Institute For Physics & Medicine GmbH
13605 W. 7th Ave.
Golden,  CO  80401
Applicant Contact ROBERT N CLARK
Correspondent
Mammendorfer Institute For Physics & Medicine GmbH
13605 W. 7th Ave.
Golden,  CO  80401
Correspondent Contact ROBERT N CLARK
Regulation Number870.2700
Classification Product Code
DQA  
Date Received01/04/2005
Decision Date 07/01/2005
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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