BRIGHT EMBRACE MODEL SBL60— 510(k) K110550

Name: FDA 510(k) clearance K110550
Creator: U.S. Food and Drug Administration
Published: 2012-02-03

Substantially Equivalent

Physician Engineered Products, Inc.

FDA 510(k) clearance K110550 for BRIGHT EMBRACE MODEL SBL60, Substantially Equivalent on 2012-02-03. Applicant: Physician Engineered Products, Inc.. Device class: 2.

Clearance details

Applicant: Physician Engineered Products, Inc.
Product code: Code LBI
Device class: Class 2
Regulation: 21 CFR 880.5700
Advisory panel: General Hospital
Date received: 2011-02-25
Decision date: 2012-02-03
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Fryeburg, ME, US

Download summary PDF View on FDA.gov ↗

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Recalls naming K110550

K-number listed on FDA's recall record

Z-2486-2015 — Bright Embrace, a Single Bili Light for newborn phototherapy Distributed by: Physician Engineered Products, Inc., Model SBL60Class II·Terminated·Physician Engineered Products, Inc.·20130831

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K110550.

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