510(k) K041120

EV APAN DIGITAL, MODEL K1VSM2000 by Afp Imaging Corp. — Product Code MUH

K041120 is an FDA 510(k) premarket notification submitted by Afp Imaging Corp. for the device "EV APAN DIGITAL, MODEL K1VSM2000". The FDA issued a decision of Substantially Equivalent on August 30, 2004. The device falls under product code MUH (System, X-Ray, Extraoral Source, Digital), a Class II device regulated under 21 CFR 872.1800. Afp Imaging Corp. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 30, 2004
Date Received
April 29, 2004
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
System, X-Ray, Extraoral Source, Digital
Device Class
Class II
Regulation Number
872.1800
Review Panel
RA
Submission Type