NEUROFAX, MODELS EEG-1100A, EEG-9100A— 510(k) K011204
Substantially EquivalentNihon Kohden America, Inc.
FDA 510(k) clearance K011204 for NEUROFAX, MODELS EEG-1100A, EEG-9100A, Substantially Equivalent on 2001-05-08. Applicant: Nihon Kohden America, Inc.. Device class: 2.
Clearance details
- Applicant
- Nihon Kohden America, Inc.
- Product code
- Code OLV
- 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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