Sentiero Desktop Diagnostic - Sentiero Desktop Diagnostic Set US6Tymp with - PATH medical GmbH

Duns Number:551540334

Device Description: Sentiero Desktop Diagnostic Set US6Tymp with IPSI, CONTRA, Reflex decay ETFContent:1. Sent Sentiero Desktop Diagnostic Set US6Tymp with IPSI, CONTRA, Reflex decay ETFContent:1. Sentiero Desktop (Tymp Diagnostic) AN100434-DG2. USB data cable AN1004183. Probe EP-TY long AN100188-US4. DD45 Contra HB7 headphone (calibrated) AN1007255. FW Reflex & Tymp class1 AN1005616. Software label printer AN1004147. 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. AN1001168. Accessory box for Tymp probe AN1005879. Accessory box AB08 AN100734-P10. Power supply adapter Senti / Sentiero Desktop USA/-UK/-EU/-AUS AN100525-USA/-UK/-EU/-AUS or AN101251-USA/-UK/-EU/-AUS optionally11. Power supply Senti / Sentiero Desktop FW7662M AN100524 or FW8002.1M AN101360 optionally12. Test cavity tymp AN100549

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More Product Details

Catalog Number

-

Brand Name

Sentiero Desktop Diagnostic

Version/Model Number

100497-US6

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

f78256dd-c4a8-44d2-9e41-0bd679767306

Public Version Date

September 29, 2022

Public Version Number

5

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