UNIVERSAL LOW PROFILE NASAL HOODS(1250,1275,1350,1450,1475,1550)— 510(k) K970046

Name: FDA 510(k) clearance K970046
Creator: U.S. Food and Drug Administration
Published: 1997-03-28

Substantially Equivalent

Accutron, Inc.

FDA 510(k) clearance K970046 for UNIVERSAL LOW PROFILE NASAL HOODS(1250,1275,1350,1450,1475,1550), Substantially Equivalent on 1997-03-28. Applicant: Accutron, Inc.. Device class: 1.

Clearance details

Applicant: Accutron, Inc.
Product code: Code KHA
Device class: Class 1
Regulation: 21 CFR 868.5590
Advisory panel: Anesthesiology
Date received: 1997-01-06
Decision date: 1997-03-28
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Phoenix, AZ, US

Download summary PDF View on FDA.gov ↗

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