510(k) K081637
K081637 is an FDA 510(k) premarket notification submitted by Konica Minolta Medical & Graphic, Inc. for the device "LASER IMAGER DRYPRO MODEL 873". The FDA issued a decision of Substantially Equivalent on July 1, 2008. The device falls under product code LMC (Camera, Multi Format, Radiological), a Class II device regulated under 21 CFR 892.2040. Konica Minolta Medical & Graphic, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- July 1, 2008
- Date Received
- June 11, 2008
- Clearance Type
- Special
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Camera, Multi Format, Radiological
- Device Class
- Class II
- Regulation Number
- 892.2040
- Review Panel
- RA
- Submission Type