HERMES HD AQ ACQUISITION STATION AND HERMES WORKSTATION— 510(k) K002782
Substantially EquivalentNuclear Diagnostics AB
FDA 510(k) clearance K002782 for HERMES HD AQ ACQUISITION STATION AND HERMES WORKSTATION, Substantially Equivalent on 2000-12-05. Applicant: Nuclear Diagnostics AB. Device class: 2.
Clearance details
- Applicant
- Nuclear Diagnostics AB
- Product code
- Code LLZ
- Device class
- Class 2
- Regulation
- 21 CFR 892.2050
- Advisory panel
- Radiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Beltsville, MD, US
Recent devices under product code LLZ
view allAdverse 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.