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cap-ONE TG-921T3

by Nihon Kohden Corporation

cap-ONE TG-921T3 is a Class II device made by Nihon Kohden Corporation, listed in FDA GUDID since 5 Sep 2016 (UDI-DI 04931921865767), registry data as of 12 Nov 2026.

Listed FDA GUDID listing, no authorization on record

Valid until

Not applicable

Database listing, no authorization

FDA recalls

Not checked

No FDA submission to match recalls against

Documents

None

No authorization documents

Trust

Unverified

Source GUDID, synced 12 Nov 2026.

Regulatory status

as of registry sync 12 Nov 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number04931921865767 UDI-DI Date5 Sep 2016ListedStatusListed GUDID: in commercial distribution

Official records

Coverage

1 jurisdiction

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  • Withdrawn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

United States — GUDID listing Listed

Specification

GUDID

Trade name
cap-ONE
Generic name
Carbon dioxide monitor
Model / Ref / Catalog
TG-921T3
Primary DI / UDI-DI
04931921865767
FDA product code
OLV, GWF, CCK, OLT
GMDN term
Carbon dioxide monitor
Device class
Class II
Regulation number
882.1400, 882.1870, 868.1400
GUDID distribution status
In Commercial Distribution

Related devices

Category: Carbon dioxide monitor

Similar devices

Other devices filed under FDA product code OLV (Standard polysomnograph with electroencephalograph).

Other devices from Nihon Kohden Corporation

See all devices from Nihon Kohden Corporation →

Properties

  • Prescription use
  • Serial number
Other properties (13, all answered No)