Eu Mdd
Eu Md Class 2a
On The Market
๐บ๐ธ United States
MADSEN Capella2
Devices (same UDI-DI)
1
Certificates
1
Countries
2
Notified Bodies
1
Basic Information
- Primary DI
- 00817020029924
- Basic UDI-DI Code
- B-00817020029924
- Reference
- 8-04-15320
- Device Types
- None provided
- Regulation
- Eu Mdd
- Classification
- Eu Md Class 2a
- Status
- On The Market
- Manufacturer
- Intelligent Hearing Systems Corp.
Additional Description
MADSEN Capella2 is a portable Otoacoustic Emission (OAE) device. One would use the OTOsuite Otoacoustic Emissions module to operate Capella2. Capella2 cannot be used without OTOsuite software. The device is power by a standard 5 V USB (Universal Serial Bus) port. Capella2 is connected to the computerโs standard USB port via a USB cable. This connection transfers the user-defined settings to be used by Capella2 and returns the acquired data. The DSP board inside Capella2 contains a digital signal processor (DSP) for real-time processing. An OAE amplifier is included for the use of the OTOsuite software.
CND Nomenclature Codes
| Code | Description |
|---|---|
| Z12149001 | OTOACOUSTIC EMISSIONS EQUIPMENT |
Certificates
| Type | Number | Notified Body | Status |
|---|---|---|---|
| MDD Annex II (excluding section 4) | 260739-2018-CE-NOR-NA-PS | DNV Product Assurance AS | Expired |
Available In Countries
๐ฉ๐ฐ Denmark
๐ฎ๐ช Ireland
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