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FDA 510(k)

SuperNO2VA Et Device

K-Number: K173147 · 2018-06-20

ApplicantRevolutionary Medical Devices, Inc.
Decision Date2018-06-20
Product CodeCCK
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

SuperNO2VA Et Device is the device name listed in this FDA 510(k) record. The listed applicant is Revolutionary Medical Devices, Inc.. It received FDA 510(k) clearance on 2018-06-20 under 510(k) number K173147. 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 SuperNO2VA Et Device?

SuperNO2VA Et Device is a medical device that received FDA 510(k) clearance on 2018-06-20. The listed applicant is Revolutionary Medical Devices, Inc.. The 510(k) number is K173147.

When did SuperNO2VA Et Device receive FDA 510(k) clearance?

SuperNO2VA Et Device received FDA 510(k) clearance on 2018-06-20, under 510(k) number K173147.

Who is the listed applicant for SuperNO2VA Et Device?

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

What is the FDA product code for SuperNO2VA Et Device?

The FDA product code for SuperNO2VA Et Device is CCK.

Other records listing Revolutionary Medical Devices, Inc. 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.

K163277SuperNO2VA Device

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

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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