TRANSTRACHEAL DEMAND OXYGEN CONTROLLER MODEL DOC-3000— 510(k) K982943

Name: FDA 510(k) clearance K982943
Creator: U.S. Food and Drug Administration
Published: 1999-07-12

Substantially Equivalent

Transtracheal Systems

FDA 510(k) clearance K982943 for TRANSTRACHEAL DEMAND OXYGEN CONTROLLER MODEL DOC-3000, Substantially Equivalent on 1999-07-12. Applicant: Transtracheal Systems. Device class: 2.

Clearance details

Applicant: Transtracheal Systems
Product code: Code NFB
Device class: Class 2
Regulation: 21 CFR 868.5905
Advisory panel: Anesthesiology
Date received: 1998-08-21
Decision date: 1999-07-12
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Boulder, CO, US

Download summary PDF View on FDA.gov ↗

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