Duns Number:338454995
Device Description: AUDIOMETER.Piano Plus VRA is an advanced clinical audiometer with two separate and indepen AUDIOMETER.Piano Plus VRA is an advanced clinical audiometer with two separate and independent channels. It is capable of performing: speech and pure-tone audiometry via air conduction, bone conduction, and free field; supra-threshold tests; High Frequency and Multi-frequency audiometry; Bekesy and MLD tests; pediatric audiometry.
Catalog Number
10300
Brand Name
PIANO
Version/Model Number
PIANO PLUS VRA
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
5e737e16-80d9-4e38-b1e2-a5baaa64d239
Public Version Date
March 29, 2018
Public Version Number
2
DI Record Publish Date
September 17, 2016
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 |