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SAC2 - Electrode Cream

by Spes Medica Srl Italy 510(k)

510(k) K192606

Product code GYB

Regulatory status

as of 24 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK192606 Date17 Jan 2020ClearedStatusActive

Coverage

1 jurisdiction

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  • Active
  • Not covered

United States — FDA 510(k) Active

Recalls: none on record (FDA, checked 22 Oct 2026)

Specification

510(k) · synced 22 Oct 2026

510(k) Number
FDA Product Code
GYB
Device Class
Class II
Regulation
21 CFR Part 882.1275
Advisory Committee
Neurology
FDA Decision
SESE Substantially Equivalent

Other devices from Spes Medica Srl

See all devices from Spes Medica Srl →

Properties & raw data

Show properties, registry sources and raw records

Sources (1)

  • FDA 510(k) K192606 24 fields · synced 22 Oct 2026