SPIRACLE TECHNOLOGY - MODEL 302 OX INHALATOR— 510(k) K963755

Name: FDA 510(k) clearance K963755
Creator: U.S. Food and Drug Administration
Published: 1997-04-08

Substantially Equivalent

Spiracle Technology

FDA 510(k) clearance K963755 for SPIRACLE TECHNOLOGY - MODEL 302 OX INHALATOR, Substantially Equivalent on 1997-04-08. Applicant: Spiracle Technology. Device class: 2.

Clearance details

Applicant: Spiracle Technology
Product code: Code CBP
Device class: Class 2
Regulation: 21 CFR 868.5870
Advisory panel: Anesthesiology
Date received: 1996-09-18
Decision date: 1997-04-08
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Irvine, CA, US

Download summary PDF View on FDA.gov ↗

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