BE 410 ENDOTRACHEAL TUBE/TRACH TUBE, PILOT REPAIR— 510(k) K884638

Name: FDA 510(k) clearance K884638
Creator: U.S. Food and Drug Administration
Published: 1988-11-23

Substantially Equivalent

Instrumentation Industries, Inc.

FDA 510(k) clearance K884638 for BE 410 ENDOTRACHEAL TUBE/TRACH TUBE, PILOT REPAIR, Substantially Equivalent on 1988-11-23. Applicant: Instrumentation Industries, Inc.. Device class: 2.

Clearance details

Applicant: Instrumentation Industries, Inc.
Product code: Code BSK
Device class: Class 2
Regulation: 21 CFR 868.5750
Advisory panel: Anesthesiology
Date received: 1988-11-07
Decision date: 1988-11-23
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Bethel Park, PA, US

Download summary PDF View on FDA.gov ↗

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