Cleared Traditional

OHMEDA-OHIO CARE PLUS INCUBATOR

K974349 · Ohmeda Medical · General Hospital
Feb 1998
Decision
85d
Days
Class 2
Risk

About This 510(k) Submission

K974349 is an FDA 510(k) clearance for the OHMEDA-OHIO CARE PLUS INCUBATOR, a Incubator, Neonatal (Class II — Special Controls, product code FMZ), submitted by Ohmeda Medical (Columbia, US). The FDA issued a Cleared decision on February 12, 1998, 85 days after receiving the submission on November 19, 1997. This device falls under the General Hospital review panel. Regulated under 21 CFR 880.5400.

Submission Details

510(k) Number K974349 FDA.gov
FDA Decision Cleared SESE
Date Received November 19, 1997
Decision Date February 12, 1998
Days to Decision 85 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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