Duns Number:338454995
Device Description: MIDDLE EAR ANALYZER.Flute Plus is a middle ear analyzer, capable of performing: tympanomet MIDDLE EAR ANALYZER.Flute Plus is a middle ear analyzer, capable of performing: tympanometry, and acoustic reflex tests in sequence and automatically, manual tympanometry, the Eustachian tube function test for intact eardrums, the reflex decay test and the facility of conducting the acoustic reflex test in manual mode. In addition, it allows to adjuste manually the pressure setting used for reflex tests. Flute Plus with Printer has, in addition, an integrated thermal printer.
Catalog Number
10341
Brand Name
FLUTE
Version/Model Number
FLUTE PLUS WITH PRINTER
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
PTO
Product Code Name
Tester, Auditory Impedance, Exempt
Public Device Record Key
f21649bd-9606-4b45-81bf-92d9dd4f1a1c
Public Version Date
June 05, 2018
Public Version Number
3
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 |