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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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Holter Server Analyzer
Lifesignals, Inc.
UA2251-SA
In Commercial Distribution

  • B353UA2251SA1 ()


  • Electrocardiographic long-term ambulatory recording analyser application software
Holter Desktop Analyzer
Lifesignals, Inc.
UA2251-DA
In Commercial Distribution

  • B353UA2251DA1 ()


  • Electrocardiographic long-term ambulatory recording analyser application software
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 Software
MORTARA INSTRUMENT, INC.
11110-005-50
In Commercial Distribution

  • 00817655022635 ()


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

  • 00817655022529 ()


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

  • 00817655022512 ()


  • Electrocardiographic long-term ambulatory recording analyser application software
Holter Analysis System
MORTARA INSTRUMENT, INC.
HSCRIBWS-6BC-DXXXX
In Commercial Distribution

  • 00817655022505 ()


  • Electrocardiographic long-term ambulatory recording analyser application software
Holter Analysis System
MORTARA INSTRUMENT, INC.
HSCRIBWS-6BC-BXXXX
In Commercial Distribution

  • 00817655022499 ()


  • Electrocardiographic long-term ambulatory recording analyser application software
Holter Analysis System
MORTARA INSTRUMENT, INC.
HSCRIBWS-6BA-CXXXX
Not in Commercial Distribution

  • 00817655022482 ()


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

  • 00817655022284 ()


  • Electrocardiographic long-term ambulatory recording analyser application software
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