MEE-1000A NEUROMASTER
FDA 510(k) clearance K051178 · decided 2005-08-17
Clearance details
- K-number
- K051178
- Device name
- MEE-1000A NEUROMASTER
- Applicant
- Nihon Kohden America, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2005-05-09
- Decision date
- 2005-08-17
- Days to decision
- 100 days
- Clearance type
- Traditional
- Product code
- GWF
- Device class
- 2
- Regulation number
- 882.1870
- Medical specialty
- Neurology
- Advisory committee
- Neurology
- Location
- Foothill, CA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| MEE-1000A Neuromaster, Model No. Accessories: MS-110B (Electric Stimulation), MS-120BK (Cu recall (Z-0817-2016) | Nihon Kohden America Inc | 2016-02-17 |