Biosign STEAM-24 Biological Indicator

FDA 510(k) K032723 · Getinge USA, Inc.

Substantially Equivalent

510(k) numberK032723

Submission

Device name
Biosign STEAM-24 Biological Indicator
Applicant
Getinge USA, Inc.
Rochester, NY, US
Received
September 3, 2003
Decision date
October 1, 2003
Decision
Substantially Equivalent (SESE)
Type
Special 510(k)
Summary
510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code
FRC – Indicator, Biological Sterilization Process
Device class
Class II (moderate risk)
Regulation
21 CFR 880.2800
Specialty
General Hospital

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Questions and answers

When was Biosign STEAM-24 Biological Indicator cleared by the FDA?

Biosign STEAM-24 Biological Indicator (K032723) received a 510(k) decision of Substantially Equivalent on October 1, 2003, 28 days after the submission was received.

What is the product code of K032723?

The FDA product code is FRC – Indicator, Biological Sterilization Process, a Class II (moderate risk) device regulated under 21 CFR 880.2800.