SIM 4000I— 510(k) K873845
Substantially EquivalentOte-Biomedica Elettronica S.P.A
FDA 510(k) clearance K873845 for SIM 4000I, Substantially Equivalent on 1988-04-07. Applicant: Ote-Biomedica Elettronica S.P.A.
Clearance details
- Applicant
- Ote-Biomedica Elettronica S.P.A
- Product code
- Code IYO
- Advisory panel
- Radiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Cambridge, MA, US
Adverse events under product code IYO
product code IYO- Malfunction
- 3,339
- Total
- 3,339
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.