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FDA 510(k)

BIOSIGN SSI BIOLOGICAL TEST PACK WITH INSTANT READOUT INTEGRATOR

K-Number: K031647 · 2003-07-29

ApplicantGetinge USA, Inc.
Decision Date2003-07-29
Product CodeJOJ
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

BIOSIGN SSI BIOLOGICAL TEST PACK WITH INSTANT READOUT INTEGRATOR 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 2003-07-29 under 510(k) number K031647. The device is classified under product code JOJ. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the BIOSIGN SSI BIOLOGICAL TEST PACK WITH INSTANT READOUT INTEGRATOR?

BIOSIGN SSI BIOLOGICAL TEST PACK WITH INSTANT READOUT INTEGRATOR is a medical device that received FDA 510(k) clearance on 2003-07-29. The listed applicant is Getinge USA, Inc.. The 510(k) number is K031647.

When did BIOSIGN SSI BIOLOGICAL TEST PACK WITH INSTANT READOUT INTEGRATOR receive FDA 510(k) clearance?

BIOSIGN SSI BIOLOGICAL TEST PACK WITH INSTANT READOUT INTEGRATOR received FDA 510(k) clearance on 2003-07-29, under 510(k) number K031647.

Who is the listed applicant for BIOSIGN SSI BIOLOGICAL TEST PACK WITH INSTANT READOUT INTEGRATOR?

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 SSI BIOLOGICAL TEST PACK WITH INSTANT READOUT INTEGRATOR?

The FDA product code for BIOSIGN SSI BIOLOGICAL TEST PACK WITH INSTANT READOUT INTEGRATOR is JOJ.

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Other records listing Getinge USA, Inc. as applicant

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.

K050664SPOR-TEST PA BIOLOGICAL INDICATOR KITK032723BIOSIGN STEAM-24 BIOLOGICAL INDICATORK031259MODEL 833HC VACUUM/GRAVITY STEAM STERILIZER

Related Devices (Code: JOJ)

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.

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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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