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FDA 510(k)

MICROSTREAM ORAL NASAL CANNULA FILTERLINE

K-Number: K011050 · 2001-05-04

ApplicantOridion Medical 1987 , Ltd.
Decision Date2001-05-04
Product CodeCCK
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

MICROSTREAM ORAL NASAL CANNULA FILTERLINE 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 2001-05-04 under 510(k) number K011050. 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 ORAL NASAL CANNULA FILTERLINE?

MICROSTREAM ORAL NASAL CANNULA FILTERLINE is a medical device that received FDA 510(k) clearance on 2001-05-04. The listed applicant is Oridion Medical 1987 , Ltd.. The 510(k) number is K011050.

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

MICROSTREAM ORAL NASAL CANNULA FILTERLINE received FDA 510(k) clearance on 2001-05-04, under 510(k) number K011050.

Who is the listed applicant for MICROSTREAM ORAL NASAL CANNULA FILTERLINE?

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 MICROSTREAM ORAL NASAL CANNULA FILTERLINE?

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

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Other records listing Oridion Medical 1987 , 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.

K200594Capnostream 35 Portable Respiratory MonitorK181624Microstream Advance Neonatal-Infant Nasal Filter Line with O2 Tubing, Microstream Advance Pediatric Oral-Nasal Filter Line with O2 Tubing, Microstream Advance Adult Oral-Nasal Filter Line with O2 Tubing, Microstream Luer Adult Oral-Nasal Sampling LineK181467Microstream Luer Adult-Pediatric Intubated Sampling Line, Microstream Advance Adult-Pediatric Intubated Filter LineK121927MICROSTREAM FILTERLINE ICUK112368CAPNOSTREAM20P WITH AI/ODIK093388SMART CAPNOLINE GUARDIAN

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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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