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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 IMAGEnet 6 ver. 2.0 is a software program that is intended for use in the collection, storage and management of digital images, patient data and diagnostic data from Topcon devices.
TOPCON HEALTHCARE SOLUTIONS, INC.
2.0
In Commercial Distribution

  • 00850003069005 ()


  • Camera application software
Software version is in Application Identifier (8012) Lot Number reflects software assembly/packaging lot number
EARLENS CORPORATION
WPUSB01
Not in Commercial Distribution

  • 00850013007110 ()
WPUSB01

  • Hearing aid/implant system programming interface unit
MoMe® Software Platform is a web-based remote server software with proprietary algorithms for analysis of ECG data. It analyzes the data via the embedded algorithm and when indicated, data identified by the algorithm is flagged for physician review. The data is sent to the Software Platform from the MoMe® Kardia , a wireless, remote monitoring system designed to aid physicians in their diagnosis of cardiac arrhythmias in patients with a demonstrated need for cardiac monitoring.
Infobionic, Inc.
1400
In Commercial Distribution

  • B690MS10 ()


  • Electrocardiographic long-term ambulatory recording analyser application software
Holter Analysis System
MORTARA INSTRUMENT, INC.
HSERV-6AA-XXXXA
In Commercial Distribution

  • 00812345029857 ()


  • Electrocardiographic long-term ambulatory recording analyser application software
Holter Analysis System
MORTARA INSTRUMENT, INC.
HSCRIBE-6AC-YXXXC
In Commercial Distribution

  • 00812345029840 ()


  • Electrocardiographic long-term ambulatory recording analyser application software
Holter Analysis System
MORTARA INSTRUMENT, INC.
HSCRIBEWS-6AC-YXXXX
In Commercial Distribution

  • 00812345029826 ()


  • Electrocardiographic long-term ambulatory recording analyser application software
Holter Analysis System
MORTARA INSTRUMENT, INC.
HSCRIBE-6AC-XXXXX
In Commercial Distribution

  • 00812345027334 ()


  • Electrocardiographic long-term ambulatory recording analyser application software
Holter Analysis System
MORTARA INSTRUMENT, INC.
HSREV-AAA-BXXAA
Not in Commercial Distribution

  • 00812345027280 ()


  • Electrocardiographic long-term ambulatory recording analyser application software
Holter Analysis System
MORTARA INSTRUMENT, INC.
HSCRIBE-5AC-XXXXB
In Commercial Distribution

  • 00812345027273 ()


  • Electrocardiographic long-term ambulatory recording analyser application software
Holter Analysis System
MORTARA INSTRUMENT, INC.
HSCRIBE-5AC-AXXXX
In Commercial Distribution

  • 00812345027266 ()


  • Electrocardiographic long-term ambulatory recording analyser application software
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