FDA 510(k)

SuperNO2VA Device

K-Number: K163277 · 2017-10-13

ApplicantRevolutionary Medical Devices, Inc.

Decision Date2017-10-13

Product CodeBSJ

Advisory CommitteeAN

DecisionSubstantially Equivalent

Device Summary

SuperNO2VA 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 2017-10-13 under 510(k) number K163277. The device is classified under product code BSJ. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SuperNO2VA Device?

SuperNO2VA Device is a medical device that received FDA 510(k) clearance on 2017-10-13. The listed applicant is Revolutionary Medical Devices, Inc.. The 510(k) number is K163277.

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

SuperNO2VA Device received FDA 510(k) clearance on 2017-10-13, under 510(k) number K163277.

Who is the listed applicant for SuperNO2VA 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 Device?

The FDA product code for SuperNO2VA Device is BSJ.

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.

K173147SuperNO2VA Et Device

Official Source

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