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Tel-O-Graph BT plus

by IEM GmbH

Tel-O-Graph BT plus is a Class II device made by IEM GmbH, cleared under FDA 510(k) K173895 on 16 May 2019 and listed in FDA GUDID since 20 Jan 2022 (UDI-DI 04041346101279), active as of 12 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 12 Nov 2026

Documents

510(k) K173895

FDA submission, from GUDID

Trust

Unverified

Source GUDID, synced 12 Nov 2026.

Regulatory status

as of registry sync 12 Nov 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number04041346101279 UDI-DI Date20 Jan 2022ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK173895 Date16 May 2019DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K173895 decided 16 May 2019 Active
  • FDA GUDID UDI-DI 04041346101279 listed 20 Jan 2022 Listed

Timeline

2 dated events

  1. Cleared FDA 510(k) K173895
  2. Listed FDA GUDID 04041346101279

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

GUDID

Trade name
Tel-O-Graph
Generic name
Telemetric sphygmomanometer
Model / reference
BT plus
Primary DI / UDI-DI
04041346101279
510(k) Number
FDA product code
DXN
GMDN term
Telemetric sphygmomanometer
Device class
Class II
Regulation number
870.1130
GUDID distribution status
In Commercial Distribution
MRI safety
MR Unsafe

Related devices

Category: Telemetric sphygmomanometer

Cleared under the same submission (K173895)

Similar devices

Other devices filed under FDA product code DXN (System, Measurement, Blood-Pressure, Non-Invasive).

Other devices from IEM GmbH

See all devices from IEM GmbH →

Properties

  • Prescription use
  • Serial number
  • Manufacturing date
Other properties (12, all answered No)