Sentiero Diagnostic - Sentiero Diagnostic TEOAE SetContent:1. Case - PATH medical GmbH

Duns Number:551540334

Device Description: Sentiero Diagnostic TEOAE SetContent:1. Case AN1005032. Inlay Sentiero AN1006773. USB data Sentiero Diagnostic TEOAE SetContent:1. Case AN1005032. Inlay Sentiero AN1006773. USB data cable AN1000894. Sentiero Diagnostic device with touchscreen AN1000985. Probe EP-DP Path long AN100028-US6. TEOAE Software AN1001097. Software label printer AN1004148. PC based Patient Management, Mira Software: Patient data & result transfer from instrument to PC, reporting options, export functions, printing via PC, data archive for Windows 10, Windows 7 etc. AN1001169. Accessory box Sentiero Combo AN10026110. Power supply Sentiero US AN101013+AN100993-USA

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More Product Details

Catalog Number

-

Brand Name

Sentiero Diagnostic

Version/Model Number

100250-US2-T

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

K133012

Product Code Details

Product Code

EWO

Product Code Name

Audiometer

Device Record Status

Public Device Record Key

206e08d7-083e-4c9d-829b-81d85157f7e8

Public Version Date

July 06, 2020

Public Version Number

1

DI Record Publish Date

June 27, 2020

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"PATH MEDICAL GMBH" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 18
2 A medical device with a moderate to high risk that requires special controls. 152