510(k) K924759
K924759 is an FDA 510(k) premarket notification submitted by Denar Corp. for the device "COLLIMATOR LIGHT SOURCE". The FDA issued a decision of Substantially Equivalent on December 9, 1992. The device falls under product code IZT (Cone, Radiographic), a Class II device regulated under 21 CFR 892.1610. Denar Corp. has at least 4 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- December 9, 1992
- Date Received
- September 23, 1992
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Cone, Radiographic
- Device Class
- Class II
- Regulation Number
- 892.1610
- Review Panel
- RA
- Submission Type