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Caroune PC809

by Shenzhen Pacom Medical Instruments Co., Ltd.

Caroune PC809 is a Class II device made by Shenzhen Pacom Medical Instruments Co., Ltd., cleared under FDA 510(k) K172889 on 25 May 2018 and listed in FDA GUDID since 31 Oct 2019 (UDI-DI 00840061480911), 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) K172889

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 Number00840061480911 UDI-DI Date31 Oct 2019ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK172889 Date25 May 2018DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K172889 decided 25 May 2018 Active
  • FDA GUDID UDI-DI 00840061480911 listed 31 Oct 2019 Listed

Timeline

2 dated events

  1. Cleared FDA 510(k) K172889
  2. Listed FDA GUDID 00840061480911

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

GUDID

Trade name
Caroune
Generic name
Infrared patient thermometer, ear/skin
Model / reference
PC809
Description
Name: Multifunctional Infrared Thermometer Model: PC809 Brand: Caroune Test Sites: Ear, Forehead Battery: 2pcs AAA batteries
Primary DI / UDI-DI
00840061480911
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 (K172889)

and 5 more cleared under K172889

Similar devices in this category

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

Other devices from Shenzhen Pacom Medical Instruments Co., Ltd.

See all devices from Shenzhen Pacom Medical Instruments Co., Ltd. →

Properties

  • Over-the-counter
  • Lot / batch number
Other properties (13, all answered No)