Sentiero Desktop Screening - Sentiero Desktop Screening Set US4Screening OAE - PATH medical GmbH

Duns Number:551540334

Device Description: Sentiero Desktop Screening Set US4Screening OAE with Screening Tymp (IPSI only)Content:1. Sentiero Desktop Screening Set US4Screening OAE with Screening Tymp (IPSI only)Content:1. Sentiero Desktop (Tymp Screening) AN100434-SB2. USB data cable AN1004183. Probe EP-TY long AN100188-US4. FW Screening Tymp class 2 AN1005605. DPOAE Quick Software AN100110-Quick6. FMDPOAE Software AN1005367. Software label printer AN1004148. Accessory box for Tymp probe AN1005879. Accessory box AB08 AN100734-P10. Power supply Senti / Sentiero Desktop FW7662M AN100524 or FW8002.1M AN101360 optionally11. Power supply adapter Senti / Sentiero Desktop USA/-UK/-EU/-AUS AN100525-USA/-UK/-EU/-AUS or AN101251-USA/-UK/-EU/-AUS optionally12. Test cavity tymp AN100549

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More Product Details

Catalog Number

-

Brand Name

Sentiero Desktop Screening

Version/Model Number

100497-US4

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

a0c6c867-c5c6-44ca-8d77-c807a32e02f1

Public Version Date

September 29, 2022

Public Version Number

6

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