Atmos

Compact device for the dry thermal examination of the vestibular organ. Characteristics: Electronically controlled air calorisator with two temperature levels to be selected, preparation…

Registry build 21.09.26

Compact device for the dry thermal examination of the vestibular organ. Characteristics: Electronically controlled air calorisator with two temperature levels to be selected, preparation mode, stimulation mode (cold or warm stimulation depending on the preselected temperature), heating off and no airflow (saving mode, standby).

1manufacturer
1catalogue number

Who Else Makes It

Registered in Beijing.

Chinese manufacturers registered for FDA product code KHH
Manufacturer City Province Registered as Device types
Isen Tech.&Trading Co., Ltd. Beijing Beijing Manufacturer 2

Record

Regulatory record for Atmos
Listed by Atmos Medizintechnik Gmbh & Co. KG, Germany
FDA product code KHH
Device type Stimulator, Caloric-Air
Device class Class 1
Regulation 21 CFR 874.1800
Establishment Repacker / relabeller, Manufacturer, Exporter
Premarket notification Exempt
Record published 2024-11-27

Specifications

Specifications
MRI safety Labeling does not contain MRI Safety Information
Label carries manufacturing date, serial number

Catalogue Numbers

Catalogue numbers for Atmos
Catalogue number Size Status
Varioair In distribution

Same Product Code

Other products under the same FDA product code
Product Sold by Catalogue numbers
Instrumentation Difra Instrumentation Difra SA 6
ICS Natus Medical Denmark ApS 4
GN Otometrics A/S Natus Medical Denmark ApS 3
Instrumentation Difra SA Instrumentation Difra SA 2
Interacoustics Interacoustics A/S 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.

Where China Actually Supplies

Every device page names the company that lists it and the factories registered to make the same thing. These are the sections with the most of them.

5,100manufacturers registered in China
2,581device types they are registered for
340,248device records, each naming its maker
31provinces with a registered manufacturer