Sentiero Desktop Diagnostic - Sentiero Desktop Diagnostic Set US9Diagnostic OAE - PATH medical GmbH

Duns Number:551540334

Device Description: Sentiero Desktop Diagnostic Set US9Diagnostic OAE with Diagnostic Tymp, Audio, DPOAE Thres Sentiero Desktop Diagnostic Set US9Diagnostic OAE with Diagnostic Tymp, Audio, DPOAE Threshold estimation software, Simultaneous DPOAE measurements on both ears (two probes incl.)Content:1. Sentiero Desktop (Tymp Diagnostic) AN100434-DG 2. USB data cable AN1004183. Probe EP-TY long AN100188-US4. Probe EP-DP VIP blue AN100539-US5. DD45 HB7 headphone (calibrated) AN100306-US6. Bone conductor B81 (calibrated) AN100888 or B71W optionally.7. Gooseneck microphone AN1007798. FW Reflex & Tymp class1 AN1005619. Software label printer AN10041410. Label printer cable Senti / Sentiero desktop AN10041711. DPOAE Software AN10011012. TEOAE Software AN10010913. DPHiRES Software AN10053714. FMDPOAE Software AN10053615. DPOAE Threshold Estimation Software AN10011116. 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. AN10011617. FW Live AN10082518. UT-08 Spondee Words for Children (English) AN10081919. UT-10 Spondee Words for Adults (English) AN10082120. UT-11 Northwestern University Auditory Test No. 6 (English) AN10082221. UT-12 Central Institute for the Deaf W22 AN10082322. UT-13 PBK-50 (English) AN10082423. Accessory box for Tymp probe AN10058724. Accessory box AB08 AN100734-P25. Power supply Senti / Sentiero Desktop FW7662M AN100524 or FW8002.1M AN101360 optionally26. Power supply adapter Senti / Sentiero Desktop USA/-UK/-EU/-AUS AN100525-USA/-UK/-EU/-AUS or AN101251-USA/-UK/-EU/-AUS optionally27. Test cavity tymp AN10054928. PTA Class 3 Software AN100114

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More Product Details

Catalog Number

-

Brand Name

Sentiero Desktop Diagnostic

Version/Model Number

100497-US9

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

fa3ac108-dcd8-4afb-ba21-b45930df95f4

Public Version Date

September 29, 2022

Public Version Number

7

DI Record Publish Date

September 16, 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