510(k) K973965
K973965 is an FDA 510(k) premarket notification submitted by Smartlight, Ltd. for the device "SMART MOTORIZED VIEWER". The FDA issued a decision of Substantially Equivalent on December 12, 1997. The device falls under product code IXC (Illuminator, Radiographic-Film), a Class I device regulated under 21 CFR 892.1890. Smartlight, Ltd. has at least 1 other 510(k) clearance on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- December 12, 1997
- Date Received
- October 17, 1997
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Illuminator, Radiographic-Film
- Device Class
- Class I
- Regulation Number
- 892.1890
- Review Panel
- RA
- Submission Type