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510(k) Data Aggregation
K Number
K072950Device Name
CYGNUS 12 LEAD ECG MODULE
Manufacturer
CYGNUS, LLC
Date Cleared
2008-08-22
(309 days)
Product Code
KRE
Regulation Number
870.3640Why did this record match?
Applicant Name (Manufacturer) :
CYGNUS, LLC
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
- The device is for prescription use only.
- The device is intended to be used in a clinic or hospital.
- The device is intended for use by the physician (or his/her representative), not by the patient, although one intended use is to record the patient's 12-lead ECG.
- The device is intended for use as a : Fully functional ECG/heart rate monitoring system for clinical use. Pacemaker Detection and measurement. A TTM (trans-telephonic) Receiving Station.
- In TTM mode, the device is intended for use with landline analog and digital PBX telephone systems only. It is not intended to be used with wireless networks.
Device Description
Cygnus 12 Lead/TTM ECG module is a fully functional ECG and Pacemaker monitoring system that is powered through a PC USB (Universal Serial Bus) port.
Four general parts could be distinguished in the Cygnus 12 Lead/TTM ECG module:
- An analog front end.
- Digital Signal Processing USB Interface Unit.
- TTM Interface for analog phone lines.
- TTM Interface for digital phones.
The module measures the 12 standard ECG leads on the isolated input, and is capable of acting as an ECG Receiving Station over the phone line for ECG and pacemaker encoded signal with Frequency Modulation (FM).
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