SuperNO2VA Device— 510(k) K163277

Name: FDA 510(k) clearance K163277
Creator: U.S. Food and Drug Administration
Published: 2017-10-13

Substantially Equivalent

Revolutionary Medical Devices, Inc.

FDA 510(k) clearance K163277 for SuperNO2VA Device, Substantially Equivalent on 2017-10-13. Applicant: Revolutionary Medical Devices, Inc.. Device class: 1.

Clearance details

Applicant: Revolutionary Medical Devices, Inc.
Product code: Code BSJ
Device class: Class 1
Regulation: 21 CFR 868.5550
Advisory panel: Anesthesiology
Date received: 2016-11-21
Decision date: 2017-10-13
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Tucson, AZ, US

Download summary PDF View on FDA.gov ↗

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