SYNAMPS (32-64 CHANNELS), ESI SYNAMPS (65-128 CHANNELS), ESI SYNAMPS (129-256 CHANNELS)— 510(k) K001324
Substantially EquivalentNeuro Scan Labs
FDA 510(k) clearance K001324 for SYNAMPS (32-64 CHANNELS), ESI SYNAMPS (65-128 CHANNELS), ESI SYNAMPS (129-256 CHANNELS), Substantially Equivalent on 2000-07-11. Applicant: Neuro Scan Labs.
Clearance details
- Applicant
- Neuro Scan Labs
- Product code
- Code OLT
- Advisory panel
- Neurology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- El Paso, TX, US
Adverse events under product code OLT
product code OLT- Other
- 1
- Total
- 1
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.