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510(k) Data Aggregation
K Number
K021239Device Name
EIKON AUTOMATIC DIGITAL BLOOD PRESSURE MONITOR, MODEL HD-400M
Manufacturer
EIKON HEALTHCARE DEVICE CORP.
Date Cleared
2002-11-08
(204 days)
Product Code
DXN
Regulation Number
870.1130Why did this record match?
Applicant Name (Manufacturer) :
EIKON HEALTHCARE DEVICE CORP.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The EIKON automatic digital blood pressure monitor, Model HD-400M, is a noninvasive blood pressure measurement system intended to measure the systolic and diastolic blood pressures and pulse rate of an adult individual, over age 16, at home by using a non-invasive technique in which an inflatable cuff is wrapped around the wrist. The cuff circumference is limited to be 5.3"-8.5".
Device Description
EIKON AUTOMATIC DIGITAL BLOOD PRESSURE MONITOR HD-400M
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K Number
K021240Device Name
EIKON AUTOMATIC DIGITAL BLOOD PRESSURE MONITOR, MODEL HD-200M/HD-200
Manufacturer
EIKON HEALTHCARE DEVICE CORP.
Date Cleared
2002-11-08
(204 days)
Product Code
DXN
Regulation Number
870.1130Why did this record match?
Applicant Name (Manufacturer) :
EIKON HEALTHCARE DEVICE CORP.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The EIKON automatic digital blood pressure monitor, Model HD-200M / HD-200, is a noninvasive blood pressure measurement system intended to measure the systolic and diastolic blood pressures and pulse rate of an adult individual, over age 16, at home by using a non-invasive technique in which an inflatable cuff is wrapped around the arm. The cuff circumference is limited to be 7"-15".
Device Description
EIKON AUTOMATIC DIGITAL BLOOD PRESSURE MONITOR HD-200M / HD-200 is a noninvasive blood pressure measurement system.
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