NSS-2 System
FDA 510(k) clearance DEN170018 · decided 2017-11-15
Clearance details
- K-number
- DEN170018
- Device name
- NSS-2 System
- Applicant
- Innovative Health Solutions (Ihs), Inc.
- Decision
- Unknown
- Date received
- 2017-03-17
- Decision date
- 2017-11-15
- Days to decision
- 243 days
- Clearance type
- Direct
- Product code
- PZR
- Device class
- 2
- Regulation number
- 882.5896
- Medical specialty
- Neurology
- Advisory committee
- Neurology
- Location
- Versailles, IN, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.