510(k) K840607
K840607 is an FDA 510(k) premarket notification submitted by Sybron Corp. for the device "LF MOTORIZED RADIOGRAPHIC FILM VIEWER". The FDA issued a decision of Substantially Equivalent on March 5, 1984. The device falls under product code IXC (Illuminator, Radiographic-Film), a Class I device regulated under 21 CFR 892.1890. Sybron Corp. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- March 5, 1984
- Date Received
- February 13, 1984
- 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