Spartan MC 0165— 510(k) K213451
Substantially EquivalentSpartan Micro
FDA 510(k) clearance K213451 for Spartan MC 0165, Substantially Equivalent on 2021-11-22. Applicant: Spartan Micro.
Clearance details
- Applicant
- Spartan Micro
- Product code
- Code QJP
- Advisory panel
- Cardiovascular
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Fremont, CA, US
Adverse events under product code QJP
product code QJP- Death
- 43
- Injury
- 233
- Malfunction
- 1,010
- Total
- 1,286
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.