FDA 510(k)
FDA class 2
Unknown
🇺🇸 United States
NSS-2 System
K Number: DEN170018
·
Decision Nov 15, 2017
Classifications
1
FEI Numbers
6
Registration Numbers
6
Same Product Code
7
Applicant Total
2
Review Days
243
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Basic Information
- Device Name
- NSS-2 System
- K Number
- DEN170018
- Device Class
- FDA class 2
- Clearance Type
- Direct
- Regulation Number
- 882.5896
- Medical Specialty
- Neurology
- Decision
- Unknown
- Applicant
- Innovative Health Solutions (Ihs), Inc.
- Date Received
- March 17, 2017
- Decision Date
- November 15, 2017
- Product Code
- PZR
- 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 |
|---|---|---|---|
| PZR | Percutaneous Nerve Stimulator For Opioid Withdrawal | FDA class 2 | Neurology |
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Other Clearances by Innovative Health Solutions (Ihs), Inc.
| K Number | Device Name | ||
|---|---|---|---|
| DEN180057 | IB-Stim | Jun 7, 2019 | Unknown |