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Jedmed 39-7405

by JEDMED Instrument Company

Jedmed 39-7405 is a Class II device made by JEDMED Instrument Company, cleared under FDA 510(k) K120982 on 28 Sep 2012 and listed in FDA GUDID since 1 Sep 2020 (UDI-DI M6333974050), active as of 23 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 23 Oct 2026

Documents

510(k) K120982

FDA submission, from GUDID

Trust

Unverified

Source GUDID, synced 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing NumberM6333974050 UDI-DI Date1 Sep 2020ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK120982 Date28 Sep 2012DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K120982 decided 28 Sep 2012 Active
  • FDA GUDID UDI-DI M6333974050 listed 1 Sep 2020 Listed

Timeline

2 dated events

  1. Cleared FDA 510(k) K120982
  2. Listed FDA GUDID M6333974050

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

GUDID

Trade name
Jedmed
Generic name
Ophthalmic fundus camera
Model / Ref / Catalog
39-7405
Primary DI / UDI-DI
M6333974050
510(k) Number
FDA product code
HKI
GMDN term
Ophthalmic fundus camera
Device class
Class II
Regulation number
886.1120
GUDID distribution status
In Commercial Distribution

Related devices

Category: Ophthalmic fundus camera

Cleared under the same submission (K120982)

and 6 more cleared under K120982

Similar devices in this category

Other devices filed under Ophthalmic fundus camera.

Other devices from JEDMED Instrument Company

See all devices from JEDMED Instrument Company →

Properties

  • Prescription use
  • Serial number
Other properties (13, all answered No)