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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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EMAS (Eko Murmur Analysis Software) - 00850010298184

The Eko Murmur Analysis Software is intended to provide decision support to clinicians in their evaluation of patients’ heart sounds. The software analyzes heart sounds and phonocardiograms (and ECG signals, when available). The software will automatically detect murmurs that may be present, and the murmur timing and character, including S1, S2, innocent heart murmurs, structural heart murmurs, and the absence of a heart murmur.
Eko Devices, Inc.
Version 1.x
In Commercial Distribution

  • 00850010298184 ()
EMAS

  • Cardiopulmonary physiological parameter analysis software

Keeler Kapture Digital Software Licence - 05055272718004

No Description
KEELER LIMITED
3020-P-7038
In Commercial Distribution

  • 05055272718004 ()


  • Ophthalmic examination slit lamp

Keeler Kapture Lite Software Licence - 05055272717991

No Description
KEELER LIMITED
3020-P-7036
In Commercial Distribution

  • 05055272717991 ()


  • Ophthalmic examination slit lamp

BAHA FITTING SOFTWARE 6 CD - 09321502074124

No Description
Cochlear Americas Corporation
P1682914CD
In Commercial Distribution

  • 09321502074124 ()


  • Hearing aid wireless-fitting computer-aided set

BAHA FITTING SOFTWARE 5 CD - 09321502074117

No Description
Cochlear Americas Corporation
P803255CD
In Commercial Distribution

  • 09321502074117 ()


  • Hearing aid wireless-fitting computer-aided set

Baha® Fitting Software 5 - 09321502044097

N/A
Cochlear Bone Anchored Solutions AB
P1457850
In Commercial Distribution

  • 09321502044097 ()
P1457850

  • Hearing aid wireless-fitting computer-aided set

Baha® Fitting Software 5.2 - 09321502038966

N/A
Cochlear Bone Anchored Solutions AB
P878156
In Commercial Distribution

  • 09321502038966 ()
P878156

  • Hearing aid wireless-fitting computer-aided set

Baha® Fitting Software 5.2 - 09321502038959

N/A
Cochlear Bone Anchored Solutions AB
P878155
Not in Commercial Distribution

  • 09321502038959 ()
P878155

  • Hearing aid wireless-fitting computer-aided set

ENDOCAPSULE SOFTWARE 10 UPGRADE PACKAGE - 04953170373848

No Description
OLYMPUS MEDICAL SYSTEMS CORP.
MAJ-2190
In Commercial Distribution

  • 14953170373845 ()
  • 04953170373848 ()
N5400540

  • Video capsule endoscopy system application software

ENDOCAPSULE SOFTWARE 10 SOFT SERVER-CLIENT - 04953170360817

No Description
OLYMPUS MEDICAL SYSTEMS CORP.
MAJ-2038
Not in Commercial Distribution

  • 04953170360817 ()
N5368840

  • Video capsule endoscopy system application software
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