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AED ENDOPRO-CAM®

NATIONAL ADVANCED ENDOSCOPY DEVICES, INC. · Model EP2000 · UDI-DI 00848657068192

510(k) clearances

Adverse events

Recalls

Facilities

Description

AED ENDOPRO-CAM® ELITE Portable HD Endoscopic Video System: An electro-optical device (e.g., with an image sensor chip) designed to be attached, either directly or with an adaptor, to a flexible or rigid endoscope to allow real-time viewing of the internal anatomy during an endoscopic surgical procedure and to obtain moving-picture documentation of endoscopic findings and procedures. The device is designed for transducing visual images as a sequence of electronic data following a pre-established standard; the images are usually displayed sequentially on the screen of a monitor as a video image. The device may include audio recording capabilities. This device includes a camera stand and rechargeable battery.

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Data compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.