Sentiero Desktop Diagnostic - Sentiero Desktop Screening TY / Diagnostic Set - PATH medical GmbH

Duns Number:551540334

Device Description: Sentiero Desktop Screening TY / Diagnostic Set US14Content:1. Carton for Sentiero Desktop Sentiero Desktop Screening TY / Diagnostic Set US14Content:1. Carton for Sentiero Desktop AN1007282. Sentiero Desktop (Tymp Diagnostic) AN100434-DG3. USB data cable AN1004184. Probe EP-TY long AN100188-US5. Headphone Interacoustics DD-45 with HB7 calibrated, incl. EEPROM AN100306-US6. Patient Response button AN1001717. FW Screening Tymp class 2 AN1005608. FW Tymp 1000 Hz AN1006899. FW PTA class 3 AN10011410. DPOAE Software AN10011011. FMDPOAE Software AN10053612. 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. AN10011613. Software label printer AN10041414. Accessory box for Tymp probe AN10058715. Accessory box AB08 AN100734-P16. Power supply Senti / Sentiero Desktop FW7662M AN100524 or FW8002.1M AN101360 optionally17. Power supply adapter Senti / Sentiero Desktop USA/-UK/-EU/-AUS AN100525-USA/-UK/-EU/-AUS or AN101251-USA/-UK/-EU/-AUS optionally18. Test cavity tymp AN100549

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More Product Details

Catalog Number

-

Brand Name

Sentiero Desktop Diagnostic

Version/Model Number

100497-US14

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

ETY

Product Code Name

Tester, Auditory Impedance

Device Record Status

Public Device Record Key

4df14bdc-325f-4552-bef8-90e99ce03c0b

Public Version Date

September 29, 2022

Public Version Number

5

DI Record Publish Date

December 02, 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