Adhesive Electrodes
FDA 510(k) clearance K160138 · decided 2016-08-11
Clearance details
- K-number
- K160138
- Device name
- Adhesive Electrodes
- Applicant
- Gmdasz Manufacturing Co., Ltd.
- Decision
- Substantially Equivalent
- Date received
- 2016-01-21
- Decision date
- 2016-08-11
- Days to decision
- 203 days
- Clearance type
- Traditional
- Product code
- GXY
- Device class
- 2
- Regulation number
- 882.1320
- Medical specialty
- Neurology
- Advisory committee
- Neurology
- Location
- Shenzhen City, CN
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.