FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
EZstim*III Peripheral Nerve Stimulator/Nerve Locator
K Number: K162048
·
Decision Dec 5, 2016
Classifications
1
FEI Numbers
53
Registration Numbers
53
Same Product Code
28
Applicant Total
1
Review Days
133
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Basic Information
- Device Name
- EZstim*III Peripheral Nerve Stimulator/Nerve Locator
- K Number
- K162048
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 868.2775
- Medical Specialty
- Anesthesiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Halyard Health - Irvine
- Date Received
- July 25, 2016
- Decision Date
- December 5, 2016
- Product Code
- KOI
- 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 |
|---|---|---|---|
| KOI | Stimulator, Nerve, Peripheral, Electric | FDA class 2 | Anesthesiology |
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