NEUROFILE DATA STORAGE/ACCESORIES TO THE EEG-4300— 510(k) K905594
Substantially EquivalentNihon Kohden America, Inc.
FDA 510(k) clearance K905594 for NEUROFILE DATA STORAGE/ACCESORIES TO THE EEG-4300, Substantially Equivalent on 1991-06-28. Applicant: Nihon Kohden America, Inc.. Device class: 2.
Clearance details
- Applicant
- Nihon Kohden America, Inc.
- Product code
- Code GWK
- Device class
- Class 2
- Regulation
- 21 CFR 882.1845
- Advisory panel
- Neurology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Irvine, CA, US
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