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FDA 510(k)

SMART CAPNOLINE GUARDIAN

K-Number: K093388 · 2010-03-04

ApplicantOridion Medical 1987 , Ltd.
Decision Date2010-03-04
Product CodeCCK
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

SMART CAPNOLINE GUARDIAN is the device name listed in this FDA 510(k) record. The listed applicant is Oridion Medical 1987 , Ltd.. It received FDA 510(k) clearance on 2010-03-04 under 510(k) number K093388. 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 SMART CAPNOLINE GUARDIAN?

SMART CAPNOLINE GUARDIAN is a medical device that received FDA 510(k) clearance on 2010-03-04. The listed applicant is Oridion Medical 1987 , Ltd.. The 510(k) number is K093388.

When did SMART CAPNOLINE GUARDIAN receive FDA 510(k) clearance?

SMART CAPNOLINE GUARDIAN received FDA 510(k) clearance on 2010-03-04, under 510(k) number K093388.

Who is the listed applicant for SMART CAPNOLINE GUARDIAN?

The FDA 510(k) record lists Oridion Medical 1987 , Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for SMART CAPNOLINE GUARDIAN?

The FDA product code for SMART CAPNOLINE GUARDIAN 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.

K251641GF-310R Multigas Unit (GF-310R)Nihon Kohden CorporationK261633VisuBreathAffirm Medical Technologies II, LLCK253030Capnostream™35 Portable Respiratory Monitor (PM35MN)Covidien, LLCK250148Medical Gas Analyzer (AG200)Prior Care Science Technology, Ltd.K243956TG-980P CO2 Sensor Kit (TG-980P); TG-980P1 CO2 Sensor Kit (TG-980P1)Nihon Kohden CorporationK2512160184 CO2 Sampling line; 0184T CO2 Sampling line; 0139 CO2 Sampling line; 0182 CO2 Sampling lineBarbaras Development, Inc.

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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