Modification to Transport Incubator 185

FDA 510(k) K031096 · International Biomedics, Inc.

Substantially Equivalent

510(k) numberK031096

Submission

Device name
Modification to Transport Incubator 185
Applicant
International Biomedics, Inc.
Austin, TX, US
Received
April 7, 2003
Decision date
June 24, 2003
Decision
Substantially Equivalent (SESE)
Type
Special 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 Modification to Transport Incubator 185 cleared by the FDA?

Modification to Transport Incubator 185 (K031096) received a 510(k) decision of Substantially Equivalent on June 24, 2003, 78 days after the submission was received.

What is the product code of K031096?

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