K122932

Substantially Equivalent

SPIRO SPEAKING VALVE WITH OXYGEN PORT SPIRO SPEAKING VALVE WITHOUT OXYGEN PORT

Applicant: Fogless International AB
Product code: JOH
Advisory panel: Anesthesiology
Date received: 2012-09-24
Decision date: 2013-12-23
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Vaggeryd, SE

Adverse events under product code JOH

product code JOH

Death: 42
Injury: 1,344
Malfunction: 5,608
Other: 1
Total: 6,995

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.