MODIFICATION TO: SPIRIT— 510(k) K080023

Name: FDA 510(k) clearance K080023
Creator: U.S. Food and Drug Administration
Published: 2008-06-16

Substantially Equivalent

Caire, Inc.

FDA 510(k) clearance K080023 for MODIFICATION TO: SPIRIT, Substantially Equivalent on 2008-06-16. Applicant: Caire, Inc.. Device class: 2.

Clearance details

Applicant: Caire, Inc.
Product code: Code BYJ
Device class: Class 2
Regulation: 21 CFR 868.5655
Advisory panel: Anesthesiology
Date received: 2008-01-04
Decision date: 2008-06-16
Decision: Substantially Equivalent
Clearance type: Special
Location: Marietta, GA, US

Download summary PDF View on FDA.gov ↗

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K103324 — PRECISION LIQUID OXYGEN SYSTEM2011-04-21
K101272 — MASS OXYGEN DISTRIBUTION SYSTEM (MODS) MODEL 10C-0061-32010-08-20
K081779 — GOLOX-932008-09-19

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K121167 — CAIRE COMPANION 5 OXYGEN CONCENTRATOR2012-05-02
K050153 — SPIRIT, MODEL HAS2005-04-15
K013251 — SPIRIT 3002001-12-18

Adverse events under product code BYJ

product code BYJ

Death: 16
Total: 16

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.