510(k) K122643

VANTAGE MODEL V5000, V5100, V5000C, V5100C by Midmark Corp. — Product Code MUH

K122643 is an FDA 510(k) premarket notification submitted by Midmark Corp. for the device "VANTAGE MODEL V5000, V5100, V5000C, V5100C". The FDA issued a decision of Substantially Equivalent on January 7, 2013. The device falls under product code MUH (System, X-Ray, Extraoral Source, Digital), a Class II device regulated under 21 CFR 872.1800. Midmark Corp. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 7, 2013
Date Received
August 29, 2012
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