510(k) K970240
K970240 is an FDA 510(k) premarket notification submitted by Focused Viewer, Inc. for the device "DIFFUSER PANEL". The FDA issued a decision of Substantially Equivalent on March 11, 1997. 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
- March 11, 1997
- Date Received
- January 22, 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