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Albatech Personal Monitor

by Albatech, Inc.

510(k) K981999

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK981999 Date4 Sep 1998ClearedStatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 22 Oct 2026.

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

510(k)

510(k) Number
FDA Product Code
GCJ
Device Class
Class II
Regulation
21 CFR Part 876.1500
Advisory Committee
Gastroenterology, Urology
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 28 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

The Albatech Personal Monitor is an eyeglass-mounted color monitor that produces a high-resolution color video image appearing in the user's eyesight. It is an ultra-lightweight device designed for mobile applications and tasks requiring concentration and focus on details.

The device is supplied as a reusable system and was cleared through the FDA 510(k) pathway under K981999 with product code GCJ. It is classified as a Class 2 General & Plastic Surgery device and received traditional 510(k) clearance on September 4, 1998, following an 88-day review.

Questions

AI-generated answers, 28 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

  • What is the Albatech Personal Monitor used for?

    The Albatech Personal Monitor is designed for mobile applications and tasks requiring concentration and focus on details, providing a high-resolution color video image that appears in the user's eyesight via an eyeglass-mounted display.

  • Is the Albatech Personal Monitor reusable or single-use?

    The Albatech Personal Monitor is supplied as a reusable system, meaning it is intended for multiple uses after appropriate cleaning and maintenance, not for single-use disposal.

  • How was the Albatech Personal Monitor cleared for market release?

    The Albatech Personal Monitor received FDA 510(k) clearance under submission K981999 on September 4, 1998, following an 88-day review, and was found substantially equivalent to a predicate device.