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Sentio 286202104

by Medos International Sàrl

Sentio 286202104 is a Class II device made by Medos International Sàrl, cleared under FDA 510(k) K173526 on 5 Apr 2018 and listed in FDA GUDID since 8 Oct 2018 (UDI-DI 20705034534746), active as of 23 Oct 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 23 Oct 2026

Documents

510(k) K173526

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 Number20705034534746 UDI-DI Date8 Oct 2018ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK173526 Date5 Apr 2018DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K173526 decided 5 Apr 2018 Active
  • FDA GUDID UDI-DI 20705034534746 listed 8 Oct 2018 Listed

Timeline

2 dated events

  1. Cleared FDA 510(k) K173526
  2. Listed FDA GUDID 20705034534746

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

GUDID

Trade name
Sentio
Generic name
Analytical non-scalp cutaneous electrode
Model / Ref / Catalog
286202104
Primary DI / UDI-DI
20705034534746
510(k) Number
FDA product code
ETN, PDQ
GMDN term
Analytical non-scalp cutaneous electrode
Device class
Class II
Regulation number
874.1820
GUDID distribution status
In Commercial Distribution

Related devices

Category: Analytical non-scalp cutaneous electrode

Cleared under the same submission (K173526)

and 5 more cleared under K173526

Similar devices in this category

Other devices filed under Analytical non-scalp cutaneous electrode.

Other devices from Medos International SARL

See all devices from Medos International SARL →

Properties

  • Single use
  • Prescription use
  • Lot / batch number
  • Expiration date
Other properties (11, all answered No)