MODIFICATION TO: SPIRIT— 510(k) K080023

Substantially Equivalent

Caire, Inc.

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

Clearance details

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

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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.