SGS ECCOVISIONTM Pharyngometer, SGS ECCOVISIONTM Rhinometer, SGS ECCOVISIONTM Rhino/Pharyngometer— 510(k) K170071

Name: FDA 510(k) clearance K170071
Creator: U.S. Food and Drug Administration
Published: 2017-11-09

Substantially Equivalent

Sleep Group Solutions

FDA 510(k) clearance K170071 for SGS ECCOVISIONTM Pharyngometer, SGS ECCOVISIONTM Rhinometer, SGS ECCOVISIONTM Rhino/Pharyngometer, Substantially Equivalent on 2017-11-09. Applicant: Sleep Group Solutions. Device class: 2.

Clearance details

Applicant: Sleep Group Solutions
Product code: Code BXQ
Device class: Class 2
Regulation: 21 CFR 868.1800
Advisory panel: Anesthesiology
Date received: 2017-01-09
Decision date: 2017-11-09
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Hollywood, FL, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code BXQ

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K221892 — VISIONAIR2022-10-05
K022311 — RHINOSTREAM RHINOMANOMETER MODULE2002-10-04
K011329 — ECCOVISION ACOUSTIC DIAGNOSTIC IMAGING ACOUSTIC PHARYNGOMETER2002-07-26
K000406 — RHINOSCAN MODEL SRE2000/ SRE2100 WITH ACOUSTIC RHINOMETRY MODULE2000-04-17
K972140 — A1 ACOUSTIC RHINOMETER1998-09-30

Data sourced from openFDA. This site is unofficial and independent of the FDA.