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FDA 510(k)

MICROSTREAM O2/CO2 ORAL NASAL FILTERLINE

K-Number: K011536 · 2001-11-14

ApplicantOridion Medical 1987 , Ltd.
Decision Date2001-11-14
Product CodeCCK
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

MICROSTREAM O2/CO2 ORAL NASAL 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 2001-11-14 under 510(k) number K011536. 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 O2/CO2 ORAL NASAL FILTERLINE?

MICROSTREAM O2/CO2 ORAL NASAL FILTERLINE is a medical device that received FDA 510(k) clearance on 2001-11-14. The listed applicant is Oridion Medical 1987 , Ltd.. The 510(k) number is K011536.

When did MICROSTREAM O2/CO2 ORAL NASAL FILTERLINE receive FDA 510(k) clearance?

MICROSTREAM O2/CO2 ORAL NASAL FILTERLINE received FDA 510(k) clearance on 2001-11-14, under 510(k) number K011536.

Who is the listed applicant for MICROSTREAM O2/CO2 ORAL NASAL 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 O2/CO2 ORAL NASAL FILTERLINE?

The FDA product code for MICROSTREAM O2/CO2 ORAL NASAL 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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