FILMSAVER, NT VERSION 5.03— 510(k) K021072
Substantially EquivalentAmerican Medical Resources, Ltd. (Amr)
FDA 510(k) clearance K021072 for FILMSAVER, NT VERSION 5.03, Substantially Equivalent on 2002-06-06. Applicant: American Medical Resources, Ltd. (Amr).
Clearance details
- Applicant
- American Medical Resources, Ltd. (Amr)
- Product code
- Code LLZ
- Advisory panel
- Radiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Wilmington, DE, US
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.