PERFORMAX SE TOTAL FACE MASK— 510(k) K072588
Substantially EquivalentRespironics Inc., Sleep & Home Respiratory Group
FDA 510(k) clearance K072588 for PERFORMAX SE TOTAL FACE MASK, Substantially Equivalent on 2007-12-18. Applicant: Respironics Inc., Sleep & Home Respiratory Group.
Clearance details
- Applicant
- Respironics Inc., Sleep & Home Respiratory Group
- Product code
- Code CBK
- Advisory panel
- Anesthesiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Murrysville, PA, US
Adverse events under product code CBK
product code CBK- Death
- 736
- Injury
- 3,628
- Malfunction
- 98,786
- Other
- 4
- Total
- 103,154
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.