ECCOVISION Pharyngometer Legacy 21000

GUDID 00860719000339

The Legacy Pharyngometer is used for an objective assessment of the oral and pharyngeal spaces

SLEEP GROUP SOLUTIONS, LLC

Acoustic rhinometer
Primary Device ID00860719000339
NIH Device Record Keybd6a513e-ae46-4873-a12d-0c3ba19d5f0b
Commercial Distribution StatusIn Commercial Distribution
Brand NameECCOVISION Pharyngometer
Version Model Number21000
Catalog NumberLegacy 21000
Company DUNS039583619
Company NameSLEEP GROUP SOLUTIONS, LLC
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchfalse
Serial Numbertrue
Manufacturing Datetrue
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone855-475-3374
Emailswi@qss-llc.com

Device Identifiers

Device Issuing AgencyDevice ID
GS100860719000339 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

BXQRhinoanemometer (Measurement Of Nasal Decongestion)

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number4
Public Version Date2019-03-12
Device Publish Date2016-09-19

Devices Manufactured by SLEEP GROUP SOLUTIONS, LLC

00860719000360 - ECCOVISION Pharyngometer and Rhinometer 2019-03-19 The ECCOVISION Pharyngometer and Rhinometer is used for an objective assessment of the oral and pharyngeal spaces
00860719000308 - ECCOVISION Rhinometer2019-03-12 The Legacy Rhinometer is used for an objective assessment of nasal cavity geometry
00860719000322 - Eccovision Rhinometer and Pharyngometer2019-03-12 The Legacy Combined Rhinometer and Pharyngometer
00860719000339 - ECCOVISION Pharyngometer2019-03-12The Legacy Pharyngometer is used for an objective assessment of the oral and pharyngeal spaces
00860719000339 - ECCOVISION Pharyngometer2019-03-12 The Legacy Pharyngometer is used for an objective assessment of the oral and pharyngeal spaces

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