Ferno Washington Incubator Transporter, Mod. 35-IT

FDA 510(k) K932417 · Ferno-Washington, Inc.

Substantially Equivalent

510(k) numberK932417

Submission

Device name
Ferno Washington Incubator Transporter, Mod. 35-IT
Applicant
Ferno-Washington, Inc.
Wilmington, OH, US
Received
May 18, 1993
Decision date
September 9, 1993
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) statement available from FDA

Official FDA 510(k) record

Device classification

Product code
FPL – Incubator, Neonatal Transport
Device class
Class II (moderate risk)
Regulation
21 CFR 880.5410
Specialty
General Hospital

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Questions and answers

When was Ferno Washington Incubator Transporter, Mod. 35-IT cleared by the FDA?

Ferno Washington Incubator Transporter, Mod. 35-IT (K932417) received a 510(k) decision of Substantially Equivalent on September 9, 1993, 114 days after the submission was received.

What is the product code of K932417?

The FDA product code is FPL – Incubator, Neonatal Transport, a Class II (moderate risk) device regulated under 21 CFR 880.5410.