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510(k) Data Aggregation
K Number
K072353Device Name
PORTABLE ECSCOPE
Manufacturer
DYANSYS CORP
Date Cleared
2007-08-30
(8 days)
Product Code
DPS
Regulation Number
870.2340Why did this record match?
Applicant Name (Manufacturer) :
DYANSYS CORP
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Portable ECScope handheld, battery operated Multi channel electrocardiograph is intended to be used for evaluation of the cardiovascular system. The Portable ECScope will acquire, display and record Multi channel ECG signals. The Portable ECScope is intended to be used by a licensed health care practitioner or under the direct supervision of a licensed health care practitioner in a hospital or health care environment. These measurements are not intended for specific clinical diagnosis. The clinical significance must be determined by a physician.
Device Description
Portable ECScope is a multi channel electrocardiograph for the simultaneous acquisition of the 7 ECG leads i.e L1, L2, L3, aVR, aVL, aVF and one of the chest leads (V1-6), featuring 3-lead Display Unit, alphanumeric keyboard and an option to print the ECG data using the Print Tool on A4 Sheet Paper or Direct Printing through connected printer. Portable ECScope can record and store in its Database up to 200 ECG tests. Each ECG test can include patient data, doctor's information and ECG measurements. Stored ECG tests can be reviewed, printed on the external printer using a PC.
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