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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name tube, tracheal (w/wo connector)
510(k) Number K893609
Device Name TEVES ECM (ENDOTRACHEAL CARDIAC MONITOR)
Applicant
LEONIDES Y. TEVES, M.D., P.A.
THE PALMS BUILDING
623-39TH STREET WEST
BRADENTON,  FL  33505
Applicant Contact LEONIDES Y TEVES
Correspondent
LEONIDES Y. TEVES, M.D., P.A.
THE PALMS BUILDING
623-39TH STREET WEST
BRADENTON,  FL  33505
Correspondent Contact LEONIDES Y TEVES
Regulation Number868.5730
Classification Product Code
BTR  
Date Received05/10/1989
Decision Date 10/30/1989
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Type Traditional
Reviewed by Third Party No
Combination Product No
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