Bili Blue F20T12/BBY and F40T12/BBY

FDA 510(k) K090192 · Interlectric Corp.

Substantially Equivalent

510(k) numberK090192

Submission

Device name
Bili Blue F20T12/BBY and F40T12/BBY
Applicant
Interlectric Corp.
Warren, PA, US
Received
January 27, 2009
Decision date
April 24, 2009
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code
LBI – Unit, Neonatal Phototherapy
Device class
Class II (moderate risk)
Regulation
21 CFR 880.5700
Specialty
General Hospital

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Questions and answers

When was Bili Blue F20T12/BBY and F40T12/BBY cleared by the FDA?

Bili Blue F20T12/BBY and F40T12/BBY (K090192) received a 510(k) decision of Substantially Equivalent on April 24, 2009, 87 days after the submission was received.

What is the product code of K090192?

The FDA product code is LBI – Unit, Neonatal Phototherapy, a Class II (moderate risk) device regulated under 21 CFR 880.5700.