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510(k) Data Aggregation
K Number
K990731Device Name
EASTGATE PERSONAL MONITOR
Manufacturer
EASTGATE TRADING CORP.
Date Cleared
1999-05-19
(75 days)
Product Code
GCJ
Regulation Number
876.1500Why did this record match?
Applicant Name (Manufacturer) :
EASTGATE TRADING CORP.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
THE EASTGATE TRADING PERSONAL MONITOR CAN BE USED FOR ANY PROCEDURE THAT REQUIRES A VIDEO DISPLAY. IT IS DESIGNED TO SIT ON THE BRIDGE OF THE NOSE. IN THIS POSITION A MEDICAL PERSON IS ABLE TO SEE THE MONITOR PICTURE AND THE SURROUNDING AREA AT THE SAME TIME.
THE PERSONAL MONITOR IS PROVIDED WITH ACCESSORIES TO PLUG INTO ANY VIDEO OUTPUT. IT CAN BE USED BY ITSELF OR IN CONJUNCTION WITH OTHER VIDEO MONITORS.
AS AN EXAMPLE IN ENDOSCOPIC SURGERY THE DOCTOR WOULD ATTACH THE VIDEO FEED TO THE REGULAR MONITOR DEVICE. BY DOING THIS THE DOCTOR COULD VIEW THE PATIENT AND THE CAMERA IMAGE AT THE SAME TIME.
AS THIS MONITOR HAS A UNIVERSAL VIDEO PLUG IT COULD BE ATTACHED TO ANY MEDICAL DEVICE WITH A VIDEO OUTPUT.
Device Description
THE PERSONAL MONITOR IS A BIOCULAR VIDEO MONITOR. DISPLAY-BIOCULAR, SINGLE LCD RESOLUTION-180,000 PIXEL OPITCAL SYSTEM-ACHROMATIC FIELD OF VIEW-18.750 DIAGONAL BRIGHTNESS 20FL CONTRAST 200:1 EYE RELIEF 28MM INTER-PUPILARY DISTANCE 58MM-77 MM ADJUSTABLE HORIZONTAL ANGULAR RESOLUTION 3,37 INTERFACE NTSC/PAL COMPOSITE POWER 7-9V DC FOCUS ADJUSTMENT- NO MONITOR BLOCK WT- 36 GRAMS MONITOR BLOCK SIZE-9.5X4X3.5CM MOUNTING EYEGLASSES. SEE THROUGH-NO SEE-AROUND-YES CONTROLLER NIT WT-80 GRMS ONTROLLER UNIT SIZE-2.0X11X5 CM &BLE DISTANCE OPTIONAL
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