Cleared Traditional

OHMEDA MEDICAL SPOT PT LITE PHOTOTHERAPY SYSTEM

K011549 · Ohmeda Medical · General Hospital
Jul 2001
Decision
62d
Days
Class 2
Risk

About This 510(k) Submission

K011549 is an FDA 510(k) clearance for the OHMEDA MEDICAL SPOT PT LITE PHOTOTHERAPY SYSTEM, a Unit, Neonatal Phototherapy (Class II — Special Controls, product code LBI), submitted by Ohmeda Medical (Laurel, US). The FDA issued a Cleared decision on July 19, 2001, 62 days after receiving the submission on May 18, 2001. This device falls under the General Hospital review panel. Regulated under 21 CFR 880.5700.

Submission Details

510(k) Number K011549 FDA.gov
FDA Decision Cleared SESE
Date Received May 18, 2001
Decision Date July 19, 2001
Days to Decision 62 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Summary PDF

Device Classification

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

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