MEM-7102; MEB-7102 EVOKED RESPONSE & ELECTRO RECOR— 510(k) K890274
Substantially EquivalentNihon Kohden America, Inc.
FDA 510(k) clearance K890274 for MEM-7102; MEB-7102 EVOKED RESPONSE & ELECTRO RECOR, Substantially Equivalent on 1989-05-18. Applicant: Nihon Kohden America, Inc.. Device class: 2.
Clearance details
- Applicant
- Nihon Kohden America, Inc.
- Product code
- Code GWF
- Device class
- Class 2
- Regulation
- 21 CFR 882.1870
- Advisory panel
- Neurology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Irvine, CA, US
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Adverse events under product code GWF
product code GWF- Malfunction
- 2,364
- Other
- 4
- Total
- 2,368
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.