FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
Neuromonitoring Kit
K Number: K161893
·
Decision Oct 18, 2016
Classifications
1
FEI Numbers
58
Registration Numbers
58
Same Product Code
34
Applicant Total
32
Review Days
99
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Basic Information
- Device Name
- Neuromonitoring Kit
- K Number
- K161893
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 874.1820
- Medical Specialty
- Ear, Nose, Throat
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- SI-BONE, Inc.
- Date Received
- July 11, 2016
- Decision Date
- October 18, 2016
- Product Code
- PDQ
- Advisory Committee
- Ear, Nose, Throat
- 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 |
|---|---|---|---|
| PDQ | Neurosurgical Nerve Locator | FDA class 2 | Ear, Nose, Throat |
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