Cleared Traditional

BILIBLANKET PLUS HIGH OUTPUT PHOTOTHERAPY SYSTEM

K040068 · Ohmeda Medical · General Hospital
Apr 2004
Decision
93d
Days
Class 2
Risk

About This 510(k) Submission

K040068 is an FDA 510(k) clearance for the BILIBLANKET PLUS HIGH OUTPUT PHOTOTHERAPY SYSTEM, a Incubator, Neonatal (Class II — Special Controls, product code FMZ), submitted by Ohmeda Medical (Laurel, US). The FDA issued a Cleared decision on April 16, 2004, 93 days after receiving the submission on January 14, 2004. This device falls under the General Hospital review panel. Regulated under 21 CFR 880.5400.

Submission Details

510(k) Number K040068 FDA.gov
FDA Decision Cleared SESE
Date Received January 14, 2004
Decision Date April 16, 2004
Days to Decision 93 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Summary PDF

Device Classification

Product Code FMZ — Incubator, Neonatal
Device Class Class II — Special Controls
CFR Regulation 21 CFR 880.5400

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