CELLO - AUDIOMETER.Cello is a portable audiometer that - INVENTIS SRL

Duns Number:338454995

Device Description: AUDIOMETER.Cello is a portable audiometer that can be controlled from a Windows computer.A AUDIOMETER.Cello is a portable audiometer that can be controlled from a Windows computer.Available exams: pure tone and speech audiometry via air conduction, bone conduction and free field; supra-threshold tests,

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More Product Details

Catalog Number

10558

Brand Name

CELLO

Version/Model Number

CELLO

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

Product Characteristics

MRI safety Status

Labeling does not contain MRI Safety Information

Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437)

-

Device labeled as "Not made with natural rubber latex"

-

For Single-Use

-

Prescription Use (Rx)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

-

Product Code Details

Product Code

EWO

Product Code Name

Audiometer

Device Record Status

Public Device Record Key

2b003cd9-2c6e-4ccf-881b-fbfc454f7020

Public Version Date

March 29, 2018

Public Version Number

2

DI Record Publish Date

September 17, 2016

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"INVENTIS SRL" Characteristics
Device Class Device Class Description No of Devices
2 A medical device with a moderate to high risk that requires special controls. 44