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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name rhinoanemometer (measurement of nasal decongestion)
510(k) Number K011329
Device Name ECCOVISION ACOUSTIC DIAGNOSTIC IMAGING ACOUSTIC PHARYNGOMETER
Applicant
E. BENSON HOOD LAB, INC.
575 WASHINGTON ST.
PEMBROKE,  MA  02359
Applicant Contact LEWIS MARTEN
Correspondent
E. BENSON HOOD LAB, INC.
575 WASHINGTON ST.
PEMBROKE,  MA  02359
Correspondent Contact LEWIS MARTEN
Regulation Number868.1800
Classification Product Code
BXQ  
Date Received05/01/2001
Decision Date 07/26/2002
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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