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FDA 510(k)

BIOSIGN STEAM-24 BIOLOGICAL INDICATOR

K-Number: K032723 · 2003-10-01

ApplicantGetinge USA, Inc.
Decision Date2003-10-01
Product CodeFRC
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

BIOSIGN STEAM-24 BIOLOGICAL INDICATOR is the device name listed in this FDA 510(k) record. The listed applicant is Getinge USA, Inc.. It received FDA 510(k) clearance on 2003-10-01 under 510(k) number K032723. The device is classified under product code FRC. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the BIOSIGN STEAM-24 BIOLOGICAL INDICATOR?

BIOSIGN STEAM-24 BIOLOGICAL INDICATOR is a medical device that received FDA 510(k) clearance on 2003-10-01. The listed applicant is Getinge USA, Inc.. The 510(k) number is K032723.

When did BIOSIGN STEAM-24 BIOLOGICAL INDICATOR receive FDA 510(k) clearance?

BIOSIGN STEAM-24 BIOLOGICAL INDICATOR received FDA 510(k) clearance on 2003-10-01, under 510(k) number K032723.

Who is the listed applicant for BIOSIGN STEAM-24 BIOLOGICAL INDICATOR?

The FDA 510(k) record lists Getinge USA, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for BIOSIGN STEAM-24 BIOLOGICAL INDICATOR?

The FDA product code for BIOSIGN STEAM-24 BIOLOGICAL INDICATOR is FRC.

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Other records listing Getinge USA, Inc. as applicant

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Related Devices (Code: FRC)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K260766Celerity 5 HP Biological Indicator (LCB052)STERIS CorporationK252680Celerity™ 20 HP Biological IndicatorSTERIS CorporationK251122Terragene® Bionova® BT20 Biological IndicatorTerrageneK251452Celerity 5 HP Biological Indicator (LCB052); Celerity 5 HP Challenge Pack (LCB059); Celerity 20 HP Biological Indicator (LCB044); Celerity 20 HP Challenge Pack (LCB045)SterisK250044Celerity 5 HP Biological Indicator (LCB052); Celerity 5 HP Challenge Pack (LCB059); Celerity 20 HP Biological Indicator (LCB044); Celerity 20 HP Challenge Pack (LCB045)STERIS CorporationK250061Celerity IncubatorSTERIS Corporation

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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