Fibroid Mapping Reviewer Application (FMRA)— 510(k) K222683
Substantially EquivalentNesa Medtech Private Limited
FDA 510(k) clearance K222683 for Fibroid Mapping Reviewer Application (FMRA), Substantially Equivalent on 2023-07-17. Applicant: Nesa Medtech Private Limited.
Clearance details
- Applicant
- Nesa Medtech Private Limited
- Product code
- Code LLZ
- Advisory panel
- Radiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Bengaluru, IN
Adverse events under product code LLZ
product code LLZ- Death
- 13
- Total
- 13
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.