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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
Predetermined Change
Control Plan Authorized		 No
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