FDA.reportPublic FDA data

ECCOVISION Rhinometer

Primary DI
00860719000308
Brand
ECCOVISION Rhinometer
Company
SLEEP GROUP SOLUTIONS, LLC
Model
11000
Catalog number
Legacy 11000
Device description
The Legacy Rhinometer is used for an objective assessment of nasal cavity geometry
Published
2016-09-01
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
BXQRhinoanemometer (Measurement Of Nasal Decongestion)

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
BXQRhinoanemometer (Measurement Of Nasal Decongestion)Anesthesiology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K921452000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K921452000ACOUSTIC RHINOMETERHood Laboratories1993-07-08BXQ

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00860719000308PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00860719000308008607190003088607190003080860719000308

GMDN Terms#

Term, Definition table
TermDefinition
Acoustic rhinometerA 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.

Sterilization Methods#

Method table
Method

Contacts#

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

Regulatory Flags#

DUNS number
039583619
Device count
1
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00860719000360ECCOVISION Pharyngometer and Rhinometer 32000ECCOVISION 320002019-03-11
00860719000322Eccovision Rhinometer and Pharyngometer31000Legacy 310002016-09-19
00860719000339ECCOVISION Pharyngometer21000Legacy 210002016-09-19

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00860009626805VISIONAIRPACIFICMD BIOTECH, LLCBXQ2023-02-07
00860719000360ECCOVISION Pharyngometer and Rhinometer SLEEP GROUP SOLUTIONS, LLCBXQ2019-03-11
05060485270034RhinomanometerGM INSTRUMENTS LIMITEDBXQ2017-11-17
00860719000322Eccovision Rhinometer and PharyngometerSLEEP GROUP SOLUTIONS, LLCBXQ2016-09-19
00860719000339ECCOVISION PharyngometerSLEEP GROUP SOLUTIONS, LLCBXQ2016-09-19
05060485270027Acoustic RhinometerGM INSTRUMENTS LIMITEDBXQ2016-08-19