Cleared Traditional

V-2200 INFANT INCUBATOR

K061280 · Neoforce Group, Inc. · General Hospital
Jun 2006
Decision
50d
Days
Class 2
Risk

About This 510(k) Submission

K061280 is an FDA 510(k) clearance for the V-2200 INFANT INCUBATOR, a Incubator, Neonatal (Class II — Special Controls, product code FMZ), submitted by Neoforce Group, Inc. (Doylestown, US). The FDA issued a Cleared decision on June 27, 2006, 50 days after receiving the submission on May 8, 2006. This device falls under the General Hospital review panel. Regulated under 21 CFR 880.5400.

Submission Details

510(k) Number K061280 FDA.gov
FDA Decision Cleared SESE
Date Received May 08, 2006
Decision Date June 27, 2006
Days to Decision 50 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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