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510(k) Data Aggregation
K Number
K061977Device Name
PELEX-04 WIRELESS ELECTROCARDIOGRAPH WITH SOFTWARE ACCESSORIES
Manufacturer
Date Cleared
2006-07-21
(8 days)
Product Code
Regulation Number
870.2920Why did this record match?
Applicant Name (Manufacturer) :
PINMED, INC
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
- 1-12 lead electrocardiograph capable of recording and transmitting standard ECGs for . the purpose of cardiac monitoring and diagnosis; the system incorporates recording/ transmitting circuitry, a package of firmware and software, and is intended for use by a medical professional
- . The ECG can be recorded and transmitted to a local or remote receiving station for consultation with a medical professional
- The ECG can be recorded and transmitted to a local or remote hand-held device or a . Personal Computer or a printer for viewing and processing
- . Allows patients at remote locations to display and transmit their ECG data to medical professionals via a communication device to a remote server
- . Intended for self-testing by patients and by healtheare professionals at home and in medical settings
Device Description
Pelex-04 wireless electrocardiograph with software accessories (Personal Heart Expert software, Pelex Server&Database software, and Pelex Explorer software)
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