Cleared Traditional

OHMEDA MEDICAL OMNIBED

K993407 · Ohmeda Medical · General Hospital
Jan 2000
Decision
89d
Days
Class 2
Risk

About This 510(k) Submission

K993407 is an FDA 510(k) clearance for the OHMEDA MEDICAL OMNIBED, a Incubator, Neonatal (Class II — Special Controls, product code FMZ), submitted by Ohmeda Medical (Columbia, US). The FDA issued a Cleared decision on January 5, 2000, 89 days after receiving the submission on October 8, 1999. This device falls under the General Hospital review panel. Regulated under 21 CFR 880.5400.

Submission Details

510(k) Number K993407 FDA.gov
FDA Decision Cleared SESE
Date Received October 08, 1999
Decision Date January 05, 2000
Days to Decision 89 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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