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510(k) Data Aggregation
K Number
K053378Device Name
LOOP RECORDER VITAPHONE, 3100 SERIES
Manufacturer
TMS TELEMEDIZINISCHE SYSTEME GMBH
Date Cleared
2006-02-23
(80 days)
Product Code
DXH
Regulation Number
870.2920Why did this record match?
Applicant Name (Manufacturer) :
TMS TELEMEDIZINISCHE SYSTEME GMBH
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Diagnostic evaluation of patients with asymptomatic and symptomatic disturbances of the cardiac rhythm such as:
- Dizziness
- Heart race
- Palpitations
- Syncopes of unknown cause
Device Description
The 3100 Series device is single-channel looping cardiac event recorder for transmitting multiple ECG recordings via land-line or GSM telephony networks to a compatible ECG receiving system, such as "sensor mobile" REMOS ECG Receiving Software (510(k) K050670) or compatible standard acoustic ECG receivers. The 3100 series device is intended for auto-triggered and patient activated event recordings (Bradycardia, Tachycardia and Atrial Fibrillation). It is battery driven and utilizes a loop-memory to capture ECG data with an adjustable pre- and post-event time.
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K Number
K050670Device Name
SENSOR MOBILE SM 100 VITAPHONE 1001R REMOS
Manufacturer
TMS TELEMEDIZINISCHE SYSTEME GMBH
Date Cleared
2005-03-30
(15 days)
Product Code
DXH
Regulation Number
870.2920Why did this record match?
Applicant Name (Manufacturer) :
TMS TELEMEDIZINISCHE SYSTEME GMBH
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Symptomatic disturbances of cardiac rhythm such as palpitations, fatigue, heart racing, fluttering, chest discomfort or pain.
Device Description
The telemedical system "sensor mobile" comprises the patient activated Tele-ECG device SM100 / vitaphone 100IR and the REMOS Receiving Software. The SM100 / vitaphone 100IR records and stores one-channel ECG episodes and transmits these data by means of a telephone or a mobile phone to a receiving station equipped with the REMOS Receiving Software for further processing. The Tele ECG device "sensor mobile" SM 100 / vitaphone 100IR, manufactured by TMS, is capable of recording, storing and transmitting up to three ECG episodes of 3C seconds each. The "sensor mobile" SM 100 is placed on the chest for post-event recording. The device is patient activated by pressing the record button. The 30-second ECG is stored in the device memory for later acoustic transmission via telephone or mobile phone in form of digital data (FSK) or via infrared (IrDA) and IrDA-enabled mobile phone to a telemedical central station equipped with the "sensor mobile" Receiving Software REMOS. The transmission is activated by pressing the send button. The device does not impair internal pacemakers and implantable cardioverters / defibrillators. The "sensor mobile" Receiving Software REMOS receives the digital ECG data via telephone line and stores it into a database. The receiving software is designed for automatic operation 24 hours a day. The ECG data will be converted to a human readable output in PDF file format with anonymized patient / user information.
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