Duns Number:370173410
Device Description: The water caloric stimulator is a device that delivers a stream of water to the ear canal The water caloric stimulator is a device that delivers a stream of water to the ear canal at controlled rates of flow and temperature and that is intended for vestibular function testing of a patient's body balance system. The vestibular stimulation of the semicircular canals produces involuntary eye movements.An internal chronometer offers through a second rotary switch the possibility to select the stimulation time. Five stimulation times are available: 20, 30, 40,50 and 60sBy default, temperature values are 27°C, 30°C, 37°C and 44°C.Minimal temperature reachable: 3°C over the ambient temperatureMaximal temperature reachable: 48°CWater flow: fixed, 350ml/minTimerRequires a water supply and an outletIntended user: Qualified users, ENT doctors, audiologist, nurses and medical staff trained to the device and to the caloric testing process.
Catalog Number
17473
Brand Name
Instrumentation Difra
Version/Model Number
AquaStar 230V 2.0
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In HIBCC
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)
Yes
Device labeled as "Not made with natural rubber latex"
-
For Single-Use
-
Prescription Use (Rx)
-
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
ETP
Product Code Name
Stimulator, Caloric-Water
Public Device Record Key
f6f29f4d-0e87-49ee-a014-b07318116389
Public Version Date
November 19, 2020
Public Version Number
2
DI Record Publish Date
September 17, 2018
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 |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 16 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 8 |