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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 K170071
Device Name SGS ECCOVISIONTM Pharyngometer, SGS ECCOVISIONTM Rhinometer, SGS ECCOVISIONTM Rhino/Pharyngometer
Applicant
Sleep Group Solutions
2035 Harding Street, Suite 200
Hollywood,  FL  33020
Applicant Contact Rani Ben-David
Correspondent
Quality Solutions and Support, LLC
PO BOX 8271
Holland,  MI  49422
Correspondent Contact Stephen W Inglese
Regulation Number868.1800
Classification Product Code
BXQ  
Date Received01/09/2017
Decision Date 11/09/2017
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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