510(k) K922848
K922848 is an FDA 510(k) premarket notification submitted by A & S Trading Co. for the device "ULTRALITE X-RAY FILM ILLUMINATOR". The FDA issued a decision of Substantially Equivalent on September 28, 1992. The device falls under product code IXC (Illuminator, Radiographic-Film), a Class I device regulated under 21 CFR 892.1890.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- September 28, 1992
- Date Received
- June 18, 1992
- 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