FDA 510(k)
FDA class 2
Substantially Equivalent
🇰🇷 South Korea
DMS Disposable Subdermal Needle Electrodes
K Number: K161566
·
Decision Dec 21, 2016
Classifications
1
FEI Numbers
64
Registration Numbers
64
Same Product Code
52
Applicant Total
3
Review Days
198
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Basic Information
- Device Name
- DMS Disposable Subdermal Needle Electrodes
- K Number
- K161566
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 882.1350
- Medical Specialty
- Neurology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Daehan Medical Systems Co., Ltd.
- Date Received
- June 6, 2016
- Decision Date
- December 21, 2016
- Product Code
- GXZ
- Advisory Committee
- Neurology
- Review Advisory Committee
- NE
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| GXZ | Electrode, Needle | FDA class 2 | Neurology |
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