SPIRO SPEAKING VALVE WITH OXYGEN PORT SPIRO SPEAKING VALVE WITHOUT OXYGEN PORT— 510(k) K122932
Substantially EquivalentFogless 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. Device class: 2.
Clearance details
- Applicant
- Fogless International AB
- Product code
- Code JOH
- Device class
- Class 2
- Regulation
- 21 CFR 868.5800
- Advisory panel
- Anesthesiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Vaggeryd, SE
Recent devices under product code JOH
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- K193133 — Blue Rhino G1-Multi Percutaneous Tracheostomy Introducer Set, Blue Rhino G1-Multi Percutaneous Tracheostomy Introducer Tray, Blue Rhino G2-Multi Percutaneous Tracheostomy Introducer Set, Blue Rhino G2-Multi Percutaneous Tracheostomy Introducer Tray, Weinmann-Multi Percutaneous Tracheostomy Exchange Set
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, through . 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.