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510(k) Data Aggregation
K Number
K150248Device Name
ORL Video NasoPharyngo-Larngoscope
Manufacturer
JEDMED INSTRUMENT COMPANY
Date Cleared
2015-07-23
(170 days)
Product Code
EQN
Regulation Number
874.4760Why did this record match?
Applicant Name (Manufacturer) :
JEDMED INSTRUMENT COMPANY
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Jedmed ORL Video Nasopharyngo-Laryngoscopes are intended to examine the larynx, nasal cavity and nasal pharynx. They are used between the upper respiratory tracts of the nasal passage and vocal cords.
Device Description
This flexible scope is designed with the insertion tube with its bendable distal tip w/camera, the handle, the umbilical unit which has the leakage tester, and connection for light source port and power/video port The handle incorporates the control lever to bend the distal tip.
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