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Company Name Brand Name GMDN Term Name GMDN Term Status FDA Product Code Name FDA Product Code Device Packaged As Sterile Sterilization Prior To Use Issuing Agency Device Size Device Size Type Device Class Implantable

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Oticon - 05714464139910

OWN SI 3 FW 1.0.0
Sbo Hearing A/S
270537
In Commercial Distribution

  • 05714464139910 ()


  • Hearing aid wireless-fitting computer-aided set

Oticon - 05714464139811

B500 FW 1.1.0
Sbo Hearing A/S
270527
In Commercial Distribution

  • 05714464139811 ()


  • Hearing aid wireless-fitting computer-aided set

Oticon - 05714464139804

B400 FW 1.1.0
Sbo Hearing A/S
270526
In Commercial Distribution

  • 05714464139804 ()


  • Hearing aid wireless-fitting computer-aided set

Oticon - 05714464139798

B300 FW 1.1.0
Sbo Hearing A/S
270525
In Commercial Distribution

  • 05714464139798 ()


  • Hearing aid wireless-fitting computer-aided set

Philips - 05714464139729

HEARLINK 3050 FW 1.1.0
Sbo Hearing A/S
270518
In Commercial Distribution

  • 05714464139729 ()


  • Hearing aid wireless-fitting computer-aided set

Bernafon - 05714464139712

ENCANTA DEMOFLEX FW 1.1.0
Sbo Hearing A/S
270517
In Commercial Distribution

  • 05714464139712 ()


  • Hearing aid wireless-fitting computer-aided set

Bernafon - 05714464139705

ENCANTA 100 FW 1.1.0
Sbo Hearing A/S
270516
In Commercial Distribution

  • 05714464139705 ()


  • Hearing aid wireless-fitting computer-aided set

DataLINK Management + Analysis Software (Version 10) - 05060481691949

The Biometrics Analysis Software is a comprehensive tool for EMG, Goniometer and associated sensor analysis including real-time data analysis as the data is collected. The Analysis software also contains all of the features of the Management Software: The DataLINK Management Software allows the user to set up the DataLINK communications with the computer, configure the sensors, collect and save the data. the Management software also contains the Dynamic Link Library for streaming data Software is available in English, Chinese, and Japanese.
BIOMETRICS LIMITED
310xx-11
In Commercial Distribution

  • 05060481691949 ()


  • Bio-energy mapping system application software

DataLINK Management Software (Version 10) - 05060481691932

The DataLINK Management Software allows the user to set up the DataLINK communications with the computer, configure the sensors, collect and save the data. the Management software also contains the Dynamic Link Library for streaming data to third party software. Software is available in English, Chinese, and Japanese.
BIOMETRICS LIMITED
310xx-00
In Commercial Distribution

  • 05060481691932 ()


  • Bio-energy mapping system application software

DataLITE Management + Analysis Software (Version 10) - 05060481690867

The Biometrics Analysis Software is a comprehensive tool for EMG, Goniometer and associated sensor analysis including real-time data analysis as the data is collected. The Analysis software also contains all of the features of the Management Software: The DataLITE Management Software allows the user to set up the DataLITE communications with the computer, configure the DataLITE sensors, collect and save the data. the Management software also contains the Dynamic Link Library for streaming data Software is available in English, Chinese, and Japanese.
BIOMETRICS LIMITED
510xx-11
In Commercial Distribution

  • 05060481690867 ()


  • Bio-energy mapping system application software
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