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FDA 510(k)

MICROSTREAM NASAL CANNULA FILTERLINE

K-Number: K980325 · 1998-04-16

ApplicantOridion Medical , Ltd.
Decision Date1998-04-16
Product CodeCCK
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

MICROSTREAM NASAL CANNULA FILTERLINE is the device name listed in this FDA 510(k) record. The listed applicant is Oridion Medical , Ltd.. It received FDA 510(k) clearance on 1998-04-16 under 510(k) number K980325. 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 MICROSTREAM NASAL CANNULA FILTERLINE?

MICROSTREAM NASAL CANNULA FILTERLINE is a medical device that received FDA 510(k) clearance on 1998-04-16. The listed applicant is Oridion Medical , Ltd.. The 510(k) number is K980325.

When did MICROSTREAM NASAL CANNULA FILTERLINE receive FDA 510(k) clearance?

MICROSTREAM NASAL CANNULA FILTERLINE received FDA 510(k) clearance on 1998-04-16, under 510(k) number K980325.

Who is the listed applicant for MICROSTREAM NASAL CANNULA FILTERLINE?

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

What is the FDA product code for MICROSTREAM NASAL CANNULA FILTERLINE?

The FDA product code for MICROSTREAM NASAL CANNULA FILTERLINE is CCK.

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Other records listing Oridion Medical , Ltd. 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.

K981114MICROCAPK980327MICROSTREAM FILTERLINE ICUK980324MICROSTREAM FILLERLINE OR/EMS

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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