NIHON KOHDEN EEG-1200A SERIES NEUROFAX, MODEL EEG-1200A— 510(k) K080546
Substantially EquivalentNihon Kohden America, Inc.
FDA 510(k) clearance K080546 for NIHON KOHDEN EEG-1200A SERIES NEUROFAX, MODEL EEG-1200A, Substantially Equivalent on 2008-08-29. Applicant: Nihon Kohden America, Inc.. Device class: 2.
Clearance details
- Applicant
- Nihon Kohden America, Inc.
- 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
- Special
- Location
- Foothill, CA, US
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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.