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

Duns Number:551540334

Device Description: Sentiero Diagnostic OAE SetContent:1. Case AN1005032. Inlay Sentiero AN1006773. USB data c Sentiero Diagnostic OAE SetContent:1. Case AN1005032. Inlay Sentiero AN1006773. USB data cable AN1000894. Sentiero Diagnostic device with touchscreen AN1000985. Probe EP-DP Path long AN100028-US6. DPOAE Software AN1001107. FMDPOAE Software AN1005368. DPHiRES Software AN1005379. Software label printer AN10041410. 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. AN10011611. Accessory Box Sentiero Combo AN100261 12. Power supply Sentiero AN101013+AN100993-USA

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More Product Details

Catalog Number

-

Brand Name

Sentiero Diagnostic

Version/Model Number

100250-US2

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

753005d4-576b-4a6f-a749-451a7d3b6879

Public Version Date

June 24, 2020

Public Version Number

4

DI Record Publish Date

August 31, 2016

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