510(k) K050693

ACCENT by Air Techniques, Inc. — Product Code MUH

K050693 is an FDA 510(k) premarket notification submitted by Air Techniques, Inc. for the device "ACCENT". The FDA issued a decision of Substantially Equivalent on May 26, 2005. The device falls under product code MUH (System, X-Ray, Extraoral Source, Digital), a Class II device regulated under 21 CFR 872.1800. Air Techniques, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 26, 2005
Date Received
March 17, 2005
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