SPIRO SPEAKING VALVE WITH OXYGEN PORT SPIRO SPEAKING VALVE WITHOUT OXYGEN PORT— 510(k) K122932

Substantially Equivalent

Fogless International AB

FDA 510(k) clearance K122932 for SPIRO SPEAKING VALVE WITH OXYGEN PORT SPIRO SPEAKING VALVE WITHOUT OXYGEN PORT, Substantially Equivalent on 2013-12-23. Applicant: Fogless International AB.

Clearance details

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

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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.