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g.HIamp 80-Channel Amplifier

by g.tec medical engineering GmbH 2 variants

g.HIamp 80-Channel Amplifier (7001), a multiple physiological signal amplifier (FDA Class II; FDA product code GWL, Amplifier, Physiological Signal) made by g.tec medical engineering GmbH, was cleared under FDA 510(k) K123255 on 20 Dec 2012 and listed in FDA GUDID on 12 Apr 2017 (UDI-DI EBCI70010); the registry lists it as not in commercial distribution (GUDID) as of 23 Oct 2026.

Active United States. Also listed in GUDID (US), not in commercial distribution.

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) K123255

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 NumberEBCI70010 UDI-DI Date12 Apr 2017ListedStatusListed GUDID: not in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK123255 Date20 Dec 2012DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K123255 decided 20 Dec 2012 Active
  • FDA GUDID UDI-DI EBCI70010 listed 12 Apr 2017 Listed

Timeline

2 dated events

  1. Cleared FDA 510(k) K123255
  2. Listed FDA GUDID EBCI70010

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

GUDID

Trade name
g.HIamp
Generic name
Multiple physiological signal amplifier
Model / Ref / Catalog
80-Channel Amplifier, 7001
Primary DI / UDI-DI
EBCI70010
510(k) Number
FDA product code
GWL
GMDN term
Multiple physiological signal amplifier
Device class
Class II
Regulation number
882.1835
GUDID distribution status
Not in Commercial Distribution

Related devices

Cleared under the same submission (K123255)

and 1 more cleared under K123255

Similar devices

Other devices filed under FDA product code GWL (Amplifier, Physiological Signal).

Other devices from g.tec medical engineering GmbH

See all devices from g.tec medical engineering GmbH →

Properties

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