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g.USBamp USB Biosignal Amplifier

by g.tec medical engineering GmbH 2 variants

g.USBamp USB Biosignal Amplifier (0216US), 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) K060803 on 2 May 2006 and listed in FDA GUDID on 23 Nov 2017 (UDI-DI EBCI0216US0); 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) K060803

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 NumberEBCI0216US0 UDI-DI Date23 Nov 2017ListedStatusListed GUDID: not in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK060803 Date2 May 2006DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K060803 decided 2 May 2006 Active
  • FDA GUDID UDI-DI EBCI0216US0 listed 23 Nov 2017 Listed

Timeline

2 dated events

  1. Cleared FDA 510(k) K060803
  2. Listed FDA GUDID EBCI0216US0

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

GUDID

Trade name
g.USBamp
Generic name
Multiple physiological signal amplifier
Model / Ref / Catalog
USB Biosignal Amplifier, 0216US
Primary DI / UDI-DI
EBCI0216US0
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

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)