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510(k) Data Aggregation
K Number
K993616Device Name
CARDIO-CARD INTERPRETATION SYSTEM I
Manufacturer
NASIFF ASSOC., INC.
Date Cleared
2000-04-10
(167 days)
Product Code
LOS
Regulation Number
N/AWhy did this record match?
Applicant Name (Manufacturer) :
NASIFF ASSOC., INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Cardio-Card interpretation program analyzes and reports abnormal and normal ECGs and possible classifications of what kind of abnormals may have been detected from ECG data sent to it. The ECG statements reported assist the user in knowing what problems may exist in the ECG. These statements are to be overread by a Physician trained in the art of ECG interpretation as no automated analysis is completely reliable.
It is intended to be used by or on the order of a physician or similarly qualified health care professional in any environmental setting that the ECG acquisition device is suitable for. These environments include hospitals, physician offices, and clinical settings.
It is intended to be used on the adult patient population.
Device Description
Cardio-Card Interpretive System I
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K Number
K972795Device Name
CARDIO-CARD MANAGEMENT SYSTEM II
Manufacturer
NASIFF ASSOC., INC.
Date Cleared
1998-02-20
(207 days)
Product Code
DXN
Regulation Number
870.1130Why did this record match?
Applicant Name (Manufacturer) :
NASIFF ASSOC., INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Cardio-Card system monitors heart mythms and reports ECGs, thythm conditions, ECG printouts, BCG measurements, NIBPs and patient demographic information (e.g. patient name, ssn, physician name, address, physician notes, test notes). The system stores the patient's data to computers for later easy retrieval from its database. The computers can be networked to allow sharing of the information also. Studies can be typical short 12-sec ECG strips and NIBPs or very long term studies.
Device Description
Cardio-Card Management System II
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K Number
K960544Device Name
CARDIO-CARD HOLTER ECG MANAGEMENT SYSTEM
Manufacturer
NASIFF ASSOC., INC.
Date Cleared
1996-08-07
(182 days)
Product Code
DRT
Regulation Number
870.2300Why did this record match?
Applicant Name (Manufacturer) :
NASIFF ASSOC., INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Device Description
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