BREATHERITE— 510(k) K981944
Substantially EquivalentVentlab Corp.
FDA 510(k) clearance K981944 for BREATHERITE, Substantially Equivalent on 1998-08-24. Applicant: Ventlab Corp.. Device class: 2.
Clearance details
- Applicant
- Ventlab Corp.
- Product code
- Code CAF
- Device class
- Class 2
- Regulation
- 21 CFR 868.5630
- Advisory panel
- Anesthesiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Crofton, MD, US
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Adverse events under product code CAF
product code CAF- Death
- 22
- Injury
- 125
- Malfunction
- 613
- Other
- 11
- Total
- 771
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.