Presygen/si-1— 510(k) K171245
Substantially EquivalentChristie Medical Holdings, Inc.
FDA 510(k) clearance K171245 for Presygen/si-1, Substantially Equivalent on 2018-08-09. Applicant: Christie Medical Holdings, Inc..
Clearance details
- Applicant
- Christie Medical Holdings, Inc.
- Product code
- Code MUD
- Advisory panel
- Cardiovascular
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Memphis, TN, US
Adverse events under product code MUD
product code MUD- Malfunction
- 467
- Total
- 467
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.