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Choicemmed Mt-118

by Beijing Choice Electronic Technology Co., Ltd.

Choicemmed Mt-118 is a Class II device made by Beijing Choice Electronic Technology Co., Ltd., cleared under FDA 510(k) K041516 on 8 Sep 2004 and listed in FDA GUDID since 24 Apr 2020 (UDI-DI 06942820462054), active as of 22 Oct 2026. One FDA recall is linked to it.

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

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None ongoing

1 closed

Documents

510(k) K041516

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 Number06942820462054 UDI-DI Date24 Apr 2020ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK041516 Date8 Sep 2004DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K041516 decided 8 Sep 2004 Active
  • FDA GUDID UDI-DI 06942820462054 listed 24 Apr 2020 Listed

Recalls

1 recall · FDA

    • Terminated Z-0506-2012 FDA Unclassified (pre-2012) initiated 23 Nov 2011

    The thermometers have been reported to have inaccurate readings

Timeline

3 dated events

  1. Cleared FDA 510(k) K041516
  2. Recall initiated FDA recalls Z-0506-2012
  3. Listed FDA GUDID 06942820462054

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

GUDID

Trade name
Choicemmed
Generic name
General-purpose patient temperature probe, single-use
Model / reference
MT-118
Primary DI / UDI-DI
06942820462054
510(k) Number
FDA product code
FLL
GMDN term
General-purpose patient temperature probe, single-use
Device class
Class II
Regulation number
880.2910
GUDID distribution status
In Commercial Distribution

Related devices

Category: General-purpose patient temperature probe, single-use

Cleared under the same submission (K041516)

and 8 more cleared under K041516

Similar devices in this category

Other devices filed under General-purpose patient temperature probe, single-use.

Other devices from Beijing Choice Electronic Technology Co., Ltd.

See all devices from Beijing Choice Electronic Technology Co., Ltd. →

Properties

  • Serial number
  • Manufacturing date
Other properties (13, all answered No)