FDA 510(k)
FDA class 2
Substantially Equivalent
🇨🇳 China
SunStim Peripheral Nerve Stimulator/Sunstim Plus Peripheral Nerve Stimulator
K Number: K153045
·
Decision May 13, 2016
Classifications
1
FEI Numbers
19
Registration Numbers
19
Same Product Code
62
Applicant Total
4
Review Days
207
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Basic Information
- Device Name
- SunStim Peripheral Nerve Stimulator/Sunstim Plus Peripheral Nerve Stimulator
- K Number
- K153045
- Device Class
- FDA class 2
- Clearance Type
- Special
- Regulation Number
- 868.2775
- Medical Specialty
- Anesthesiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Easy Med Instrument Co., Ltd.
- Date Received
- October 19, 2015
- Decision Date
- May 13, 2016
- Product Code
- BXN
- Advisory Committee
- Anesthesiology
- Review Advisory Committee
- AN
- 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 |
|---|---|---|---|
| BXN | Stimulator, Nerve, Battery-Powered | FDA class 2 | Anesthesiology |
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