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Aeon A350

by Shenzhen Aeon Technology Co., Ltd.

Aeon A350 is a Class II device made by Shenzhen Aeon Technology Co., Ltd., cleared under FDA 510(k) K190869 on 13 Sep 2019 and listed in FDA GUDID since 18 Sep 2019 (UDI-DI 06947832500305), active as of 22 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 22 Oct 2026

Documents

510(k) K190869

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 Number06947832500305 UDI-DI Date18 Sep 2019ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k) from GUDID NumberK190869 Date13 Sep 2019IssuedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K190869 decided 13 Sep 2019 Active
  • FDA GUDID UDI-DI 06947832500305 listed 18 Sep 2019 Listed

Timeline

2 dated events

  1. Cleared FDA 510(k) K190869
  2. Listed FDA GUDID 06947832500305

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

GUDID

Trade name
Aeon
Generic name
Pulse oximeter
Model / reference
A350
Primary DI / UDI-DI
06947832500305
510(k) Number
FDA product code
DQA
GMDN term
Pulse oximeter
Device class
Class II
Regulation number
870.2700
GUDID distribution status
In Commercial Distribution
MRI safety
MR Unsafe

Related devices

Category: Pulse oximeter

Cleared under the same submission (K190869)

and 1 more cleared under K190869

Similar devices in this category

Other devices filed under Pulse oximeter.

Other devices from Shenzhen Aeon Technology Co., Ltd.

See all devices from Shenzhen Aeon Technology Co., Ltd. →

Properties

  • Serial number
Other properties (14, all answered No)