NITRONOX(R), FIRST RESPONSE NITRONOX(TM)— 510(k) K883833

Name: FDA 510(k) clearance K883833
Creator: U.S. Food and Drug Administration
Published: 1989-02-17

Substantially Equivalent

Matrix Medica, Inc.

FDA 510(k) clearance K883833 for NITRONOX(R), FIRST RESPONSE NITRONOX(TM), Substantially Equivalent on 1989-02-17. Applicant: Matrix Medica, Inc.. Device class: 2.

Clearance details

Applicant: Matrix Medica, Inc.
Product code: Code BZR
Device class: Class 2
Regulation: 21 CFR 868.5330
Advisory panel: Anesthesiology
Date received: 1988-09-09
Decision date: 1989-02-17
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Orchard Park, NY, US

Download summary PDF View on FDA.gov ↗

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