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FDA 510(k)

AIR BARRIER SYSTEM (ABS)

K-Number: K123006 · 2013-12-20

ApplicantNimbic Systems, Inc.
Decision Date2013-12-20
Product CodeORC
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

AIR BARRIER SYSTEM (ABS) is the device name listed in this FDA 510(k) record. The listed applicant is Nimbic Systems, Inc.. It received FDA 510(k) clearance on 2013-12-20 under 510(k) number K123006. The device is classified under product code ORC. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the AIR BARRIER SYSTEM (ABS)?

AIR BARRIER SYSTEM (ABS) is a medical device that received FDA 510(k) clearance on 2013-12-20. The listed applicant is Nimbic Systems, Inc.. The 510(k) number is K123006.

When did AIR BARRIER SYSTEM (ABS) receive FDA 510(k) clearance?

AIR BARRIER SYSTEM (ABS) received FDA 510(k) clearance on 2013-12-20, under 510(k) number K123006.

Who is the listed applicant for AIR BARRIER SYSTEM (ABS)?

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

What is the FDA product code for AIR BARRIER SYSTEM (ABS)?

The FDA product code for AIR BARRIER SYSTEM (ABS) is ORC.

Related Clinical Trials

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Related Devices (Code: ORC)

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.

K190027SteriStayToul Meditech ABK173349OperioToul Meditech ABK163455SurgiCubeSurgicube International B.V.K153498OperioToul Meditech ABK092801ABS BLOWER, ABS NOZZLE, MODEL 1001Nimbic Systems, LLC

Official Source

View on FDA Database →

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

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