MODEL MEB-5304 EVOKED POTENTIAL & ELECTRO. RECORD— 510(k) K881177
Substantially EquivalentNihon Kohden America, Inc.
FDA 510(k) clearance K881177 for MODEL MEB-5304 EVOKED POTENTIAL & ELECTRO. RECORD, Substantially Equivalent on 1988-09-30. Applicant: Nihon Kohden America, Inc.. Device class: 2.
Clearance details
- Applicant
- Nihon Kohden America, Inc.
- Product code
- Code GWL
- Device class
- Class 2
- Regulation
- 21 CFR 882.1835
- Advisory panel
- Neurology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Irvine, CA, US
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