GMDASZ TENS ELECTRODES, MODELS CWN1005, DIA. 5CM, DWN2505, 5CMX5CM, CWN1007.DIA. 7CM, CWN2509,5CMX9CM— 510(k) K092546
Substantially EquivalentGmdasz Manufacturing Co., Ltd.
FDA 510(k) clearance K092546 for GMDASZ TENS ELECTRODES, MODELS CWN1005, DIA. 5CM, DWN2505, 5CMX5CM, CWN1007.DIA. 7CM, CWN2509,5CMX9CM, Substantially Equivalent on 2009-12-18. Applicant: Gmdasz Manufacturing Co., Ltd.. Device class: 2.
Clearance details
- Applicant
- Gmdasz Manufacturing Co., Ltd.
- Product code
- Code GXY
- Device class
- Class 2
- Regulation
- 21 CFR 882.1320
- Advisory panel
- Neurology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Echo, OR, US
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More clearances from Gmdasz Manufacturing Co., Ltd.
view allData sourced from openFDA. This site is unofficial and independent of the FDA.