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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 K052544
Device Name PULSE OXIMETER ADAPTER CABLES
Applicant
AMERICAN I.V. PRODUCTS, INC.
7485 SHIPLEY AVE.
HANOVER,  MD  21076
Applicant Contact GREGORY FALK
Correspondent
AMERICAN I.V. PRODUCTS, INC.
7485 SHIPLEY AVE.
HANOVER,  MD  21076
Correspondent Contact GREGORY FALK
Regulation Number870.2700
Classification Product Code
DQA  
Date Received09/15/2005
Decision Date 09/29/2006
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Anesthesiology
Summary Summary
Type Abbreviated
Reviewed by Third Party No
Combination Product No
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