ActTrust— 510(k) K151784

Substantially Equivalent

Condor Instruments Ltda. - Epp

FDA 510(k) clearance K151784 for ActTrust, Substantially Equivalent on 2016-05-25. Applicant: Condor Instruments Ltda. - Epp. Device class: 2.

Clearance details

Applicant: Condor Instruments Ltda. - Epp
Product code: Code LEL
Device class: Class 2
Regulation: 21 CFR 882.5050
Advisory panel: Neurology
Date received: 2015-07-01
Decision date: 2016-05-25
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Sao Paulo, BR

Download summary PDF View on FDA.gov ↗

Recent devices under product code LEL

K252981 — EmbraceMini2025-12-22
K251574 — Sleep Watch2025-07-31
K243513 — DCM (PW-DCM)2025-04-16
K233987 — VERABAND2024-06-17
K233618 — Oxevision Sleep Device2024-04-03

Data sourced from openFDA. This site is unofficial and independent of the FDA.