GN Otometrics A/S
3 catalogue numbers from "AirCal Caloric Stimulator, Extended, listed by Natus Medical Denmark ApS, Denmark, under Stimulator, Caloric-Air. 1 manufacturer in China is registered for this product code.
1manufacturer
3catalogue numbers in this listing
Who Else Makes It
Registered in Beijing.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Isen Tech.&Trading Co., Ltd. | Beijing | Beijing | Manufacturer | 2 |
Record
| Listed by | Natus Medical Denmark ApS, Denmark |
|---|---|
| FDA product code | KHH |
| Device type | Stimulator, Caloric-Air |
| Device class | Class 1 |
| Regulation | 21 CFR 874.1800 |
| Establishment | Specification developer, Complaint-file establishment, Manufacturer |
| Premarket notification | Exempt |
| Record published | 2016-09-19 |
| Record revised | 2025-10-30 (version 6) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Label carries | lot or batch number, manufacturing date, serial number |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| “AirCal Caloric Stimulator, Extended | In distribution | |
| Specula, disposable | In distribution | |
| “AirCal Caloric Stimulator, Extended | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Instrumentation Difra | Instrumentation Difra SA | 6 |
| ICS | Natus Medical Denmark ApS | 4 |
| Instrumentation Difra SA | Instrumentation Difra SA | 2 |
| Interacoustics | Interacoustics A/S | 1 |
| Atmos | Atmos Medizintechnik Gmbh & Co. KG | 1 |
Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.