FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
CHECKPOINT
K Number: K092292
·
Decision Oct 28, 2009
Classifications
1
FEI Numbers
140
Registration Numbers
140
Same Product Code
96
Applicant Total
3
Review Days
91
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Basic Information
- Device Name
- CHECKPOINT
- K Number
- K092292
- 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
- Ndi Medical, LLC
- Date Received
- July 29, 2009
- Decision Date
- October 28, 2009
- Product Code
- ETN
- Advisory Committee
- Ear, Nose, Throat
- Review Advisory Committee
- EN
- 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 |
|---|---|---|---|
| ETN | Stimulator, Nerve | FDA class 2 | Ear, Nose, Throat |
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