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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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Senti Set 2 - 04260223142963

Senti Audiometry (Class 3) Set Content: 1. Case AN100503 2. Inlay Sentiero AN100677 3. Senti device with touchscreen AN100097 4. FW Labelprinter AN100414 5. Pure Tone Audiometer Class 3 AN100114 6. Headphone HDA-280 AN100117 7. Bone conductor B71 with patient response button AN100214 8. Power supply AN100083 9. USB data cable AN100089
PATH medical GmbH
100450
Not in Commercial Distribution

  • 04260223142963 ()


  • Tone audiometer

encevis - 09120109830122

encevis is a quantitative EEG trending, spike and seizure detection software. encevis is used for both monitoring and trending of EEG recordings during acquisition and reviewing of processed recordings.
AIT Austrian Institute of Technology GmbH
1.12
In Commercial Distribution

  • 09120109830122 ()


  • Bioelectrical signal analysis software

encevis - 09120109830078

encevis is a quantitative EEG trending, spike and seizure detection software. encevis is used for both monitoring and trending of EEG recordings during acquisition and reviewing of processed recordings.
AIT Austrian Institute of Technology GmbH
1.6
In Commercial Distribution

  • 09120109830078 ()


  • Bioelectrical signal analysis software

TONOPORT VI - 04260671371021

No Description
PAR Medizintechnik GmbH & Co. Kommanditgesellschaft
2001589-202
In Commercial Distribution

  • 04260671371021 ()


  • Blood pressure ambulatory recorder

Senti Set 1 - 04260223143151

Senti Audiometry (Class 4 Advanced) Set Content: 1. Case AN100503 2. Inlay Sentiero AN100677 3. Senti device with touchscreen AN100097 4. FW Labelprinter AN100414 5. Pure Tone Audiometer Class 4A AN100653 6. Headphone HDA-280 AN100117 7. Power supply AN100083 8. USB data cable AN100089
PATH medical GmbH
100330
Not in Commercial Distribution

  • 04260223143151 ()


  • Tone audiometer

Senti Desktop Flex (Basic Set) - 04260223142987

Senti Desktop Flex Basic Set Content: 1. Case AN100503 2. Inlay Sentiero AN100385 3. Senti Desktop Flex device AN100433 4. Headphone DD-45 AN100306 5. FW Labelprinter AN100414 6. FW Pure Tone Audiometer Class 3 AN100114 7. Bone Conductor B81 AN100888 or B71W AN100344 optionally 8. Patient response button AN100171 9. Power supply AN100524 + AN100525-USA or AN101360 + AN101251-USA optionally 10. USB data cable AN100418
PATH medical GmbH
100470
In Commercial Distribution

  • 04260223142987 ()


  • Tone audiometer

Senti Set 3 - 04260223142970

Senti Audiometry (Class 3 with HF) Set Content: 1. Case AN100503 2. Inlay Sentiero AN100677 3. Senti device with touchscreen AN100097 4. FW Labelprinter AN100414 5. Pure Tone Audiometer Class 3 AN100114 6. Pure Tone Audiometer High Frequency AN100454 7. Headphone HDA-300 AN100630 8. Bone conductor B-71 with Patient Response button AN100214 9. Power supply AN100083 10. USB data cable AN100089
PATH medical GmbH
100460
Not in Commercial Distribution

  • 04260223142970 ()


  • Tone audiometer

Senti - 04260223142529

Senti device with touchscreen
PATH medical GmbH
100097
Not in Commercial Distribution

  • 04260223142529 ()


  • Tone audiometer

Senti Desktop - 04260223142505

Senti Desktop device with touchscreen
PATH medical GmbH
100433
In Commercial Distribution

  • 04260223142505 ()


  • Tone audiometer

Maico - 04260176120902

No Description
MAICO Diagnostics GmbH
MA 42
Not in Commercial Distribution

  • 04260176120902 ()


  • Tone audiometer
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