510(k) K933830
K933830 is an FDA 510(k) premarket notification submitted by Konica Medical Corp. for the device "KONICA LD-4500 LASER DIGITIZER". The FDA issued a decision of Substantially Equivalent on December 14, 1993. The device falls under product code LMA (Digitizer, Image, Radiological), a Class II device regulated under 21 CFR 892.2030. Konica Medical Corp. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- December 14, 1993
- Date Received
- August 5, 1993
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Digitizer, Image, Radiological
- Device Class
- Class II
- Regulation Number
- 892.2030
- Review Panel
- RA
- Submission Type