Smartlight Digital Film Viewer, Models Sl 4000PLUS, Sl 2000PLUS
by Smartlight, Inc. 510(k)
Active
510(k) K991302
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK991302 | Date1 Jun 1999 | StatusActive |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Recalls
No FDA recalls on record, checked 12 Oct 2026.
Specification
- 510(k) Number
- FDA Product Code
- IXC
- Device Class
- Class I
- Regulation
- 21 CFR Part 892.1890
- Advisory Committee
- Radiology
- FDA Decision
- SESE Substantially Equivalent