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iProvèn DMT-77BT

by Sevenground Trading B.V.

iProvèn DMT-77BT is a Class II device made by Sevenground Trading B.V., cleared under FDA 510(k) K172795 on 14 Mar 2018 and listed in FDA GUDID since 28 Nov 2022 (UDI-DI 08719699636552), 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) K172795

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 Number08719699636552 UDI-DI Date28 Nov 2022ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k) from GUDID NumberK172795 Date14 Mar 2018IssuedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K172795 decided 14 Mar 2018 Active
  • FDA GUDID UDI-DI 08719699636552 listed 28 Nov 2022 Listed

Timeline

2 dated events

  1. Cleared FDA 510(k) K172795
  2. Listed FDA GUDID 08719699636552

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

GUDID

Trade name
iProvèn
Generic name
Infrared patient thermometer, ear/skin
Model / reference
DMT-77BT
Primary DI / UDI-DI
08719699636552
510(k) Number
FDA product code
FLL
GMDN term
Infrared patient thermometer, ear/skin
Device class
Class II
Regulation number
880.2910
GUDID distribution status
In Commercial Distribution

Related devices

Category: Infrared patient thermometer, ear/skin

Cleared under the same submission (K172795)

and 8 more cleared under K172795

Similar devices in this category

Other devices filed under Infrared patient thermometer, ear/skin.

Other devices from Sevenground Trading B.V.

See all devices from Sevenground Trading B.V. →

Properties

  • Lot / batch number
Other properties (14, all answered No)