• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

510(k) Premarket Notification

  • Print
  • Share
  • E-mail
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC

New Search Back To Search Results
Device Classification Name rhinoanemometer (measurement of nasal decongestion)
510(k) Number K170071
Device Name SGS ECCOVISIONTM Pharyngometer, SGS ECCOVISIONTM Rhinometer, SGS ECCOVISIONTM Rhino/Pharyngometer
Sleep Group Solutions
2035 Harding Street, Suite 200
Hollywood,  FL  33020
Applicant Contact Rani Ben-David
Quality Solutions and Support, LLC
PO BOX 8271
Holland,  MI  49422
Correspondent Contact Stephen W Inglese
Regulation Number868.1800
Classification Product Code
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