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Keyboard Maj-1995

by Olympus Medical Systems Corporation

Keyboard Maj-1995 (N4505940) is a Class II device made by Olympus Medical Systems Corporation, cleared under FDA 510(k) K130058 on 22 Feb 2013 and listed in FDA GUDID since 21 Sep 2016 (UDI-DI 04953170356797), active as of 22 Oct 2026.

Active United States. Also listed in GUDID (US).

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

510(k) K130058

FDA submission, from GUDID

Trust

Unverified

Source GUDID, synced 22 Oct 2026.

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number04953170356797 UDI-DI Date21 Sep 2016ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK130058 Date22 Feb 2013DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K130058 decided 22 Feb 2013 Active
  • FDA GUDID UDI-DI 04953170356797 listed 21 Sep 2016 Listed

Timeline

2 dated events

  1. Cleared FDA 510(k) K130058
  2. Listed FDA GUDID 04953170356797

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

GUDID

Trade name
Keyboard
Generic name
Computer/medical device keyboard
Model / Ref / Catalog
MAJ-1995, N4505940
Primary DI / UDI-DI
04953170356797
FDA product code
IYN, ODG, ITX, IYO
GMDN term
Computer/medical device keyboard
Device class
Class II
Regulation number
892.1550, 876.1500, 892.1570, 892.1560
GUDID distribution status
In Commercial Distribution

Related devices

Category: Computer/medical device keyboard

Cleared under the same submission (K130058)

Similar devices

Other devices filed under FDA product code IYN (System, imaging, pulsed doppler, ultrasonic).

Other devices from Olympus Medical Systems Corporation

See all devices from Olympus Medical Systems Corporation →

Properties

  • Prescription use
  • Serial number
  • Manufacturing date
Other properties (12, all answered No)