INFANT PHOTOTHERAPY BILITRON SKY 5006— 510(k) K131196

Name: FDA 510(k) clearance K131196
Creator: U.S. Food and Drug Administration
Published: 2014-02-20

Substantially Equivalent

Fanem Lda

FDA 510(k) clearance K131196 for INFANT PHOTOTHERAPY BILITRON SKY 5006, Substantially Equivalent on 2014-02-20. Applicant: Fanem Lda. Device class: 2.

Clearance details

Applicant: Fanem Lda
Product code: Code LBI
Device class: Class 2
Regulation: 21 CFR 880.5700
Advisory panel: General Hospital
Date received: 2013-04-26
Decision date: 2014-02-20
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Aventura, FL, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code LBI

view all

K251308 — SnugLit(TM) Wearable Phototherapy System (SNGL-01-US)2026-01-15
K243372 — BiliWrap2025-05-29
K210289 — Infant Phototherapy Equipment2021-05-28
K200031 — Neonatal Phototherapy System2020-10-05
K190899 — bili-hut2019-09-05

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