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510(k) Data Aggregation
K Number
K050097Device Name
TECHNO-SCOPE VISUAL STETHOSCOPE
Manufacturer
Date Cleared
2005-09-30
(259 days)
Product Code
Regulation Number
870.1875Why did this record match?
Applicant Name (Manufacturer) :
TECHTRADE LLC
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The Techno-Scope projects sounds associated with the heart, arteries, and veins and other internal organs. It also acquires the electrical signal from electrodes and produces a visual display of the electrocardiograph signal and heart rate.
The Techno-Scope is not intended to be used as a diagnostic device.
Device Description
The Techno-Scope™ Visual Stethoscope is comprised of a manual stethoscope which can project sounds associated with the heart, arteries, veins and other internal organs. It also has an electrocardiograph (ECG) display unit. The electrocardiograph consists of 3 leadless nondisposable electrodes. It is placed on the chestpiece of the stethoscope, opposite the diaphragm. It can display real time ECG through high resolution LCD. It also calculates and displays the heart rate according to the ECG. The healthcare professional can listen to internal organ sounds simultaneously while seeing the ECG signals.
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K Number
K042145Device Name
READY-HEAT BLANKET
Manufacturer
Date Cleared
2004-09-17
(39 days)
Product Code
Regulation Number
880.6060Why did this record match?
Applicant Name (Manufacturer) :
TECHTRADE LLC
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
To provide warm relief
Device Description
Ready Heat™ blanket
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