DeviceClearance

SYNAMPS (32-64 CHANNELS), ESI SYNAMPS (65-128 CHANNELS), ESI SYNAMPS (129-256 CHANNELS)— 510(k) K001324

Substantially Equivalent

Neuro 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. Device class: 2.

Clearance details

Applicant
Neuro Scan Labs
Product code
Code OLT
Device class
Class 2
Regulation
21 CFR 882.1400
Advisory panel
Neurology
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
El Paso, TX, US
Download summary PDFView on FDA.gov ↗

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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.