510(k) K061999

DRY LASER IMAGER, DRYPRO MODEL 832 by Konica Minolta Medical & Graphic, Inc. — Product Code LMC

K061999 is an FDA 510(k) premarket notification submitted by Konica Minolta Medical & Graphic, Inc. for the device "DRY LASER IMAGER, DRYPRO MODEL 832". The FDA issued a decision of Substantially Equivalent on August 15, 2006. 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
August 15, 2006
Date Received
July 14, 2006
Clearance Type
Traditional
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