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510(k) Data Aggregation
K Number
K042002Device Name
SYNESCOPE, EASYSCOPE, SYNECOM, HOLTERREADER
Manufacturer
ELA MEDICAL INC
Date Cleared
2004-10-20
(86 days)
Product Code
DQK
Regulation Number
870.1425Why did this record match?
Applicant Name (Manufacturer) :
ELA MEDICAL INC
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
SyneScope™ is intended to analyze, edit, review, report, store and transfer multi-channel ECG recording on pediatric or adult patients (for periods up to 96 hours). These recordings are provided by:
- SpiderView™ Holter ECG recorder (K032466), -
- SyneFlash™ Holter ECG (K990727), or ﺴ
- other compatible cassette tape recorder. -
In addition, any ISHNE compatible recording can be read by SyneScope™
EasyScope™ is intended to analyze, edit, review, report, store and transfer 2-3 channel ECG recording on pediatric or adult patients (for periods up to 96 hours). These recordings are provided by:
- SpiderView™ Holter ECG recorder (K032466), -
- SyneFlash™ Holter ECG (K990727), or -
- other compatible cassette tape recorder. -
SyneCom™ is intended to download, transfer for analysis, print and store multi-channel ECG recordings on pediatric or adult patients (for periods up to 96 hours). These recordings are provided by:
- SpiderView™ Holter ECG recorder (K032466), -
- SyneFlash™ Holter ECG (K990727) -
HolterReader is intended to view and print Holter reports from SyneScope™ p orts of TM and Comment The TW EasyScope™ and SyneCom™ .
SyneScope™, EasyScope™, SyneCom™ and HolterReader are intended to be used under the supervision of licensed and trained practitioners, in a hospital or clinic setting. Applications for Holter monitoring include, but are not limited to, evaluation of the following:
- Patient symptoms such as syncope, dizziness or palpitations. .
- Ischemia, especially in patients who cannot exercise or in patients with variant . angina.
- Function of an implanted pacemaker or defibrillator. .
Device Description
SyneScope™, EasyScope™, SyneCom™ and HolterReader are software applications that Syncocope - ; Lasy Seoper recordings obtained with an ELA Medical Holter ECG digital and & U [SuneFlash™( K990727) and SpiderView™(K032466)], a standard cassette tape recorder, or an ISHNE compatible recording (for SyneScope™ only).
SyneScope™, EasyScope™, SyneCom™ and HolterReader are Microsoft Windows-based Dynoodoop ; Lasy oopersonal computers equipped with flash-card readers and/or tape cassette readers.
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