Sentiero Desktop AuditData Tymp + OAE - Sentiero Desktop Auditdata Diagnsotic Set AD2, - PATH medical GmbH

Duns Number:551540334

Device Description: Sentiero Desktop Auditdata Diagnsotic Set AD2, Tymp+ OAE.Content:1. Sentiero Desktop (Tymp Sentiero Desktop Auditdata Diagnsotic Set AD2, Tymp+ OAE.Content:1. Sentiero Desktop (Tymp Diagnostic) AN100434-DW2. Ear probe EP-TY AN100188-US3. USB data cable AN1004184. Software label printer AN1004145. FW Screening Tymp Class 2 AN1005606. FW DPOAE AN1001107. FW FMDPOAE AN1005368. FW DPHiRes AN1005379. Accessory box for Tymp Auditdata AN100587-AD10. Accessory box AB08 AN100734-P11. Power supply adapter Senti / Sentiero Desktop USA/-UK/-EU/-AUS AN100525-USA/-UK/-EU/-AUS or 101251-USA/-UK/-EU/-AUS optionally12. Power supply Senti / Sentiero Desktop FW7662M AN100524 or FW8002.1M AN101360 optionally13. Test cavity tymp AN100549

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More Product Details

Catalog Number

-

Brand Name

Sentiero Desktop AuditData Tymp + OAE

Version/Model Number

100497-AD2

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

5e17d66a-44b8-4d67-aaf6-a893a97e4c1d

Public Version Date

September 29, 2022

Public Version Number

6

DI Record Publish Date

May 26, 2017

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