SPROTTE SPECIAL NRFit
by Pajunk GmbH Medizintechnologie
510(k) K160296
SPROTTE SPECIAL NRFit is a Class II device made by Pajunk GmbH Medizintechnologie, cleared under FDA 510(k) K160296 on 27 Oct 2016, active as of 22 Oct 2026.
Active
510(k)
Valid until
No expiry
FDA recalls
None found
Documents
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK160296 | Date27 Oct 2016 | StatusActive |
Official records
- FDA 510(k) database K160296
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA product code
- BSP
- Device class
- Class II
- Regulation
- 21 CFR Part 868.5150
- Advisory committee
- Anesthesiology
- FDA decision
- SESE Substantially Equivalent
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