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510(k) Data Aggregation
K Number
K993878Device Name
JE 2000
Manufacturer
Date Cleared
2000-02-01
(78 days)
Regulation Number
890.1375Why did this record match?
Applicant Name (Manufacturer) :
JACK'S ELECTRODES
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The electromyograph is intended to be used by a licensed practitioner, for the purpose of diagnostic neurological procedures.
Device Description
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K Number
K974119Device Name
DISPOSABLE NEEDLE ELECTRODE (ALM), DISPOSABLE NEEDLE ELECTRODE (DLM)
Manufacturer
Date Cleared
1998-01-28
(89 days)
Product Code
Regulation Number
882.1350Why did this record match?
Applicant Name (Manufacturer) :
JACK'S ELECTRODES
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
Acute Cardiac Ischemia Time-Insensitive Instrument (ACI-TIPI ) Option is intended to be used in a hospital or clinic environment by competent health professionals . TIPI utilizes recorded ECG data along with patient demographic and chest pain status to produce a numerical score which is the predicted probability of acute cardiac ischemia. Like any computer-assisted ECG interpretation program, the Marquette ACI-TIPI evaluation and probability score is intended to supplement, not substitue for the physician's decision process. It should be used in conjunction with knowledge of the patient's history, the results of a physical examination, the ECG tracing, and other clinical findings.
ACI-TIP! is intended for adult patient populations.
Device Description
Acute Cardiac Ischemia Time-Insensitive Predictive Instrument (ACI-TIPI ) Option is a software option for Marquette MAC-series electrocardiographs to aid the physician's decision-making process in a chest pain setting by using patient age, gender, chest pain status and ECG features to provide the predicted probability of acute cardiac ischemia (which includes unstable angina pectoris and acute myocardial infarction).
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