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CD3A

by Aei Technologies, Inc.

CD3A (150200) is a Class II device made by Aei Technologies, Inc., cleared under FDA 510(k) K942113 on 16 Feb 1995 and listed in FDA GUDID since 3 Nov 2021 (UDI-DI B9671502000), active as of 8 Nov 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 8 Nov 2026

Documents

510(k) K942113

FDA submission, from GUDID

Trust

Unverified

Source GUDID, synced 8 Nov 2026.

Regulatory status

as of registry sync 8 Nov 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing NumberB9671502000 UDI-DI Date3 Nov 2021ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK942113 Date16 Feb 1995DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K942113 decided 16 Feb 1995 Active
  • FDA GUDID UDI-DI B9671502000 listed 3 Nov 2021 Listed

Timeline

2 dated events

  1. Cleared FDA 510(k) K942113
  2. Listed FDA GUDID B9671502000

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

GUDID

Generic name
Carbon dioxide monitor
Model / Ref / Catalog
CD3A, 150200
Primary DI / UDI-DI
B9671502000
510(k) Number
FDA product code
CCK
GMDN term
Carbon dioxide monitor
Device class
Class II
Regulation number
868.1400
GUDID distribution status
In Commercial Distribution

Related devices

Category: Carbon dioxide monitor

Similar devices

Other devices filed under FDA product code CCK (Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase).

Other devices from Aei Technologies, Inc.

  • Maxii

    Class II

  • Moxus

    Class II

  • S3A

    Class II

  • MAXIIa

    Class II

Properties

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