Cleared Traditional

FERNO-WASHINGTON INCUBATOR TRANSPORTER,# 29-IT

K931346 · Ferno · General Hospital
Aug 1993
Decision
161d
Days
Class 2
Risk

About This 510(k) Submission

K931346 is an FDA 510(k) clearance for the FERNO-WASHINGTON INCUBATOR TRANSPORTER,# 29-IT, a Incubator, Neonatal Transport (Class II — Special Controls, product code FPL), submitted by Ferno (Wilmington, US). The FDA issued a Cleared decision on August 25, 1993, 161 days after receiving the submission on March 17, 1993. This device falls under the General Hospital review panel. Regulated under 21 CFR 880.5410.

Submission Details

510(k) Number K931346 FDA.gov
FDA Decision Cleared SESE
Date Received March 17, 1993
Decision Date August 25, 1993
Days to Decision 161 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Statement

Device Classification

Product Code FPL — Incubator, Neonatal Transport
Device Class Class II — Special Controls
CFR Regulation 21 CFR 880.5410

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