SILBERG T.P.S., TISSUE PREPARATION SYSTEM, MODEL ME 800— 510(k) K023083
Substantially Equivalent - Subject to Tracking Reg.Mettler Electronics Corp.
FDA 510(k) clearance K023083 for SILBERG T.P.S., TISSUE PREPARATION SYSTEM, MODEL ME 800, Substantially Equivalent - Subject to Tracking Reg. on 2003-02-28. Applicant: Mettler Electronics Corp..
Clearance details
- Applicant
- Mettler Electronics Corp.
- Product code
- Code FRN
- Advisory panel
- General Hospital
- Date received
- Decision date
- Decision
- Substantially Equivalent - Subject to Tracking Reg.
- Clearance type
- Abbreviated
- Location
- Anaheim, CA, US
Adverse events under product code FRN
product code FRN- Death
- 540
- Injury
- 6,178
- Malfunction
- 1,464,165
- Other
- 52
- Total
- 1,470,935
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.