Cleared Traditional

CENTURA PHOTOTHERAPY SPOTLIGHT

K010495 · Medical Illumination International, Inc. · General Hospital
Mar 2001
Decision
17d
Days
Class 2
Risk

About This 510(k) Submission

K010495 is an FDA 510(k) clearance for the CENTURA PHOTOTHERAPY SPOTLIGHT, a Unit, Neonatal Phototherapy (Class II — Special Controls, product code LBI), submitted by Medical Illumination International, Inc. (San Fernando, US). The FDA issued a Cleared decision on March 9, 2001, 17 days after receiving the submission on February 20, 2001. This device falls under the General Hospital review panel. Regulated under 21 CFR 880.5700.

Submission Details

510(k) Number K010495 FDA.gov
FDA Decision Cleared SESE
Date Received February 20, 2001
Decision Date March 09, 2001
Days to Decision 17 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Statement

Device Classification

Product Code LBI — Unit, Neonatal Phototherapy
Device Class Class II — Special Controls
CFR Regulation 21 CFR 880.5700

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