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510(k) Data Aggregation
K Number
K062364Device Name
I-SCOPE 200
Manufacturer
Date Cleared
2006-12-06
(114 days)
Product Code
Regulation Number
870.1875Why did this record match?
Applicant Name (Manufacturer) :
DONGJIN MEDICAL CO., LTD
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The i-Scope 200 is intended for medical diagnostic purposes only. It can be used for the amplification of heart, lung and other body sounds with the use of selective frequency and can be used on any patient undergoing a physical assessment.
Device Description
i-scope 200 digital stethoscope is a new advanced product compared to conventional stethoscopes that removes noise from tube of standard stethoscope. It dose not cause pain to the ear despite long-term use due to newly introduced soft materials applied in earphone. i-scope 200 digital stethoscope is intended for medical diagnostic purposes only. It is used for the amplification of heart, lung and other body sounds with selective frequency filtering. This product is not designed, sold, or intended for any other use.
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