Demand Nasal Oxygen Cannula, Modified Demand Nasal Oxygen Cannula— 510(k) K151506

Name: FDA 510(k) clearance K151506
Creator: U.S. Food and Drug Administration
Published: 2016-03-11

Substantially Equivalent

Salter Labs

FDA 510(k) clearance K151506 for Demand Nasal Oxygen Cannula, Modified Demand Nasal Oxygen Cannula, Substantially Equivalent on 2016-03-11. Applicant: Salter Labs. Device class: 2.

Clearance details

Applicant: Salter Labs
Product code: Code NFB
Device class: Class 2
Regulation: 21 CFR 868.5905
Advisory panel: Anesthesiology
Date received: 2015-06-04
Decision date: 2016-03-11
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Carlsbad, CA, US

Download summary PDF View on FDA.gov ↗

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