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FDA 510(k)

POLARIS 2004 CAPNOGRAPH

K-Number: K040011 · 2004-05-13

ApplicantOridion , Ltd.
Decision Date2004-05-13
Product CodeCCK
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

POLARIS 2004 CAPNOGRAPH is the device name listed in this FDA 510(k) record. The listed applicant is Oridion , Ltd.. It received FDA 510(k) clearance on 2004-05-13 under 510(k) number K040011. The device is classified under product code CCK. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the POLARIS 2004 CAPNOGRAPH?

POLARIS 2004 CAPNOGRAPH is a medical device that received FDA 510(k) clearance on 2004-05-13. The listed applicant is Oridion , Ltd.. The 510(k) number is K040011.

When did POLARIS 2004 CAPNOGRAPH receive FDA 510(k) clearance?

POLARIS 2004 CAPNOGRAPH received FDA 510(k) clearance on 2004-05-13, under 510(k) number K040011.

Who is the listed applicant for POLARIS 2004 CAPNOGRAPH?

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

What is the FDA product code for POLARIS 2004 CAPNOGRAPH?

The FDA product code for POLARIS 2004 CAPNOGRAPH is CCK.

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Related Devices (Code: CCK)

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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