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FDA 510(k)

LOFLO C5 CO2 SENSOR

K-Number: K053174 · 2006-01-12

ApplicantRespironics Novametrix, LLC
Decision Date2006-01-12
Product CodeCCK
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

LOFLO C5 CO2 SENSOR is the device name listed in this FDA 510(k) record. The listed applicant is Respironics Novametrix, LLC. It received FDA 510(k) clearance on 2006-01-12 under 510(k) number K053174. 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 LOFLO C5 CO2 SENSOR?

LOFLO C5 CO2 SENSOR is a medical device that received FDA 510(k) clearance on 2006-01-12. The listed applicant is Respironics Novametrix, LLC. The 510(k) number is K053174.

When did LOFLO C5 CO2 SENSOR receive FDA 510(k) clearance?

LOFLO C5 CO2 SENSOR received FDA 510(k) clearance on 2006-01-12, under 510(k) number K053174.

Who is the listed applicant for LOFLO C5 CO2 SENSOR?

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

What is the FDA product code for LOFLO C5 CO2 SENSOR?

The FDA product code for LOFLO C5 CO2 SENSOR is CCK.

Related Clinical Trials

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Other records listing Respironics Novametrix, LLC 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.

K103578PHILIPS NM3 RESPIRATORY MONITOR WITH VENTASSISTK091459PHILIPS NM3 MONITOR, MODEL 7900K080652MERCURY VCO2 MODULE WITH CAPNOSTAT 5

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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