Duns Number:338454995
Device Description: MIDDLE EAR ANALYZER / AUDIOMETER.Timpani is a portable middle ear analyzer / audiometer, c MIDDLE EAR ANALYZER / AUDIOMETER.Timpani is a portable middle ear analyzer / audiometer, capable of performing tympanometry.With additional licenses, it can perform acoustic ipsi-reflex tests in sequence and automatically and pure tone audiometry using air conduction.
Catalog Number
11440
Brand Name
TIMPANI
Version/Model Number
TIMPANI
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In GS1
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
-
Product Code
EWO
Product Code Name
Audiometer
Public Device Record Key
8d1812cc-e201-4851-87a7-f623d4647d14
Public Version Date
April 24, 2019
Public Version Number
1
DI Record Publish Date
April 16, 2019
Package DI Number
None
Quantity per Package
-
Contains DI Package
-
Package Discontinue Date
-
Package Status
-
Package Type
-
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 2 | A medical device with a moderate to high risk that requires special controls. | 44 |