ECCOVISION Pharyngometer and Rhinometer

Primary DI: 00860719000360
Brand: ECCOVISION Pharyngometer and Rhinometer
Company: SLEEP GROUP SOLUTIONS, LLC
Model: 32000
Catalog number: ECCOVISION 32000
Device description: The ECCOVISION Pharyngometer and Rhinometer is used for an objective assessment of the oral and pharyngeal spaces
Published: 2019-03-11
Public version status: New
Distribution status: In Commercial Distribution
MRI safety: Labeling does not contain MRI Safety Information
Rx: true

Contact Domains#

Code, Name table
Code	Name
BXQ	Rhinoanemometer (Measurement Of Nasal Decongestion)

Code, Device, Specialty table
Code	Device	Specialty	Class
BXQ	Rhinoanemometer (Measurement Of Nasal Decongestion)	Anesthesiology	2

Submission, Supplement table
Submission	Supplement
K170071	000

Submission, Supplement, Device table
Submission	Supplement	Device	Applicant	Decision date	Product code
K170071	000	SGS ECCOVISIONTM Pharyngometer, SGS ECCOVISIONTM Rhinometer, SGS ECCOVISIONTM Rhino/Pharyngometer	Sleep Group Solutions	2017-11-09	BXQ

Identifier, Type, Agency table
Identifier	Type	Agency	Package quantity	Status
00860719000360	Primary	GS1	0

Source identifier, GTIN-14 normalized, UPC-A table
Source identifier	GTIN-14 normalized	UPC-A	EAN-13
00860719000360	00860719000360	860719000360	0860719000360

Term, Definition table
Term	Definition
Acoustic rhinometer	A line-powered (AC-powered), or powered via a connected computer, electronic device designed to allow the internal profile of the nose to be recorded in order to quantify the degree of obstruction/congestion in the nasal cavities and provide monitoring of the consequences of therapy or surgery. A nosepiece conducts a sound pulse produced by an integrated sound generator to the patient?s nose and the sound reflections from the nose are detected where changes in cross-sectional areas are encountered. It is a computer-based device with dedicated software for processing the outgoing and return signals to produce plots of cross-sectional areas as a function of distance in the nose.

Method table
Method

Phone, Email table
Phone	Email
855-475-3374	swi@qss-llc.com

Primary DI, Brand, Model table
Primary DI	Brand	Model	Catalog	Published
00860719000308	ECCOVISION Rhinometer	11000	Legacy 11000	2016-09-01
00860719000322	Eccovision Rhinometer and Pharyngometer	31000	Legacy 31000	2016-09-19
00860719000339	ECCOVISION Pharyngometer	21000	Legacy 21000	2016-09-19

Primary DI, Brand, Company table
Primary DI	Brand	Company	Product code	Published
00860009626805	VISIONAIR	PACIFICMD BIOTECH, LLC	BXQ	2023-02-07
05060485270034	Rhinomanometer	GM INSTRUMENTS LIMITED	BXQ	2017-11-17
00860719000322	Eccovision Rhinometer and Pharyngometer	SLEEP GROUP SOLUTIONS, LLC	BXQ	2016-09-19
00860719000339	ECCOVISION Pharyngometer	SLEEP GROUP SOLUTIONS, LLC	BXQ	2016-09-19
00860719000308	ECCOVISION Rhinometer	SLEEP GROUP SOLUTIONS, LLC	BXQ	2016-09-01
05060485270027	Acoustic Rhinometer	GM INSTRUMENTS LIMITED	BXQ	2016-08-19