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Braun IRT6500AM

by Kaz USA, Inc.

Braun IRT6500AM is a Class II device made by Kaz USA, Inc., cleared under FDA 510(k) K103800 on 26 Jan 2011 and listed in FDA GUDID since 28 Sep 2018 (UDI-DI 00328785001945), 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) K103800

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 Number00328785001945 UDI-DI Date28 Sep 2018ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Special NumberK103800 Date26 Jan 2011DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K103800 decided 26 Jan 2011 Active
  • FDA GUDID UDI-DI 00328785001945 listed 28 Sep 2018 Listed

Timeline

2 dated events

  1. Cleared FDA 510(k) K103800
  2. Listed FDA GUDID 00328785001945

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

GUDID

Trade name
Braun
Generic name
Infrared patient thermometer, ear
Model / reference
IRT6500AM
Primary DI / UDI-DI
00328785001945
FDA product code
FLL
GMDN term
Infrared patient thermometer, ear
Device class
Class II
Regulation number
880.2910
GUDID distribution status
In Commercial Distribution

Related devices

Category: Infrared patient thermometer, ear

Cleared under the same submission (K103800)

and 8 more cleared under K103800

Similar devices

Other devices filed under FDA product code FLL (Thermometer, Electronic, Clinical).

Other devices from Kaz USA, Inc.

See all devices from Kaz USA, Inc. →

Properties

  • Over-the-counter
Other properties (14, all answered No)