Cleared Special

BILIBLANKET PLUS HIGH OUTPUT PHOTOTHERAPY SYSTEM

K993712 · Ohmeda Medical · General Hospital
Nov 1999
Decision
6d
Days
Class 2
Risk

About This 510(k) Submission

K993712 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 (Columbia, US). The FDA issued a Cleared decision on November 9, 1999, 6 days after receiving the submission on November 3, 1999. This device falls under the General Hospital review panel. Regulated under 21 CFR 880.5400.

Submission Details

510(k) Number K993712 FDA.gov
FDA Decision Cleared SESE
Date Received November 03, 1999
Decision Date November 09, 1999
Days to Decision 6 days
Submission Type Special
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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