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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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SOFTWARE, SINGLE FIBER, MEB-9400
NIHON KOHDEN CORPORATION
QP-947BK
In Commercial Distribution

  • 04931921104835 ()
QP-947BK

  • Evoked-potential graphic recording system
SOFTWARE, QUANT EMG , MEB-9400
NIHON KOHDEN CORPORATION
QP-946BK
In Commercial Distribution

  • 04931921104828 ()
QP-946BK

  • Evoked-potential graphic recording system
EEG examination support software
NIHON KOHDEN CORPORATION
QP-150AK
In Commercial Distribution

  • 04931921100783 ()
QP-150AK

  • Electroencephalograph
COMPUTERIZED SPEECH LAB (SOFTWARE)
PENTAX OF AMERICA, INC.
4500B
In Commercial Distribution

  • 04961333236589 ()


  • Speech assistive training device
PHONATORY AERODYNAMIC SYSTEM (SOFTWARE)
PENTAX OF AMERICA, INC.
6600
In Commercial Distribution

  • 04961333236565 ()


  • Electroglottograph
CAPE V SOFTWARE MODULE
PENTAX OF AMERICA, INC.
5168
In Commercial Distribution

  • 04961333235421 ()


  • Electroglottograph
SOFTWARE KEY, USB HASP-4
PENTAX OF AMERICA, INC.
1111-1322
In Commercial Distribution

  • 04961333231157 ()


  • Electroglottograph
Motor Speech Products, Software
PENTAX OF AMERICA, INC.
5141
In Commercial Distribution

  • 04961333229802 ()


  • Electroglottograph
Real-Time EGG Analysis Software
PENTAX OF AMERICA, INC.
5138
In Commercial Distribution

  • 04961333229796 ()


  • Electroglottograph
Analysis-Synthesis Laboratory (ASL) Software
PENTAX OF AMERICA, INC.
5104
Not in Commercial Distribution

  • 04961333229734 ()


  • Electroglottograph
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