# K990731: Eastgate Personal Monitor

- Pathway: 510(k) (Traditional)
- Applicant: Eastgate Trading Corp.
- Decided: May 19, 1999 after 75 days
- Product code: GCJ (Laparoscope, General & Plastic Surgery)
- Device class: 2
- Regulation: 21 CFR 876.1500
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 4 generations back to K923160 (1992). 5 ancestors in all.
No later device cites it as a predicate yet.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K981999: Albatech Personal Monitor, Albatech, Inc. (1998)
- K961343: Medvision Personal Monitor, Medvision, Inc. (1997)

## Indications for use
'E EASTGATE TRADING PERSONAL MONITOR CAN BE USED FOR ANY PROCEDURE _.HAT REQUIRES A VIDEO DISPLAY.IT IS DESIGNED TO SIT ON THE BRIDGE OF THE NOSE.IN THIS POSITION A MEDICAL PERSON 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.

Source page: https://510kreport.com/device/K990731
Methodology: https://510kreport.com/methodology