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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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The BSD-2000 system is a prescription device that is intended to deliver hyperthermia, which has been shown to increase the sensitivity of tumor cells to radiation or chemotherapy by the external application of electromagnetic energy. The system provides hyperthermia to solid tumors by generating and applying radio frequency (RF) energy.
Pyrexar Medical Inc.
BSD-2000B
In Commercial Distribution



  • Microwave hyperthermia system
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
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
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 to third party software. Software is available in English, Chinese, and Japanese.
BIOMETRICS LIMITED
510xx-100
In Commercial Distribution

  • 05060481690850 ()


  • Bio-energy mapping system application software
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
AMICA-GEN MW GENERATOR 250W
H.S. HOSPITAL SERVICE SPA
AMICA-GEN
In Commercial Distribution

  • 08058983744864 ()
AGN-3.3

  • Microwave hyperthermia system
AMICA-GEN MW/RF GENERATOR 250W/200W
H.S. HOSPITAL SERVICE SPA
AMICA-GEN
In Commercial Distribution

  • 08058983744772 ()
AGN-H-1.3

  • Microwave hyperthermia system
AMICA-GEN MW/RF GENERATOR 190W/200W
H.S. HOSPITAL SERVICE SPA
AMICA-GEN
In Commercial Distribution

  • 08058983742488 ()
AGN-H-1.2

  • Microwave hyperthermia system
AMICA-GEN MW GENERATOR 190W
H.S. HOSPITAL SERVICE SPA
AMICA-GEN
In Commercial Distribution

  • 08058983742471 ()
AGN-3.2

  • Microwave hyperthermia system
AMICA-GEN MW/RF GENERATOR 140W/200W
H.S. HOSPITAL SERVICE SPA
AMICA-GEN
In Commercial Distribution

  • 08058983742457 ()
AGN-H-1.1

  • Microwave hyperthermia system
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