CONSOLIDATED SR AND SSE MC-SERIES STEAM STERILIZER— 510(k) K041833
Substantially EquivalentConsolidated Machine Corp.
FDA 510(k) clearance K041833 for CONSOLIDATED SR AND SSE MC-SERIES STEAM STERILIZER, Substantially Equivalent on 2004-12-10. Applicant: Consolidated Machine Corp..
Clearance details
- Applicant
- Consolidated Machine Corp.
- Product code
- Code FLE
- Advisory panel
- General Hospital
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Abbreviated
- Location
- Boston, MA, US
Adverse events under product code FLE
product code FLE- Malfunction
- 444
- Total
- 444
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.