510(k) K040556

TROPHYPAN C WITH ORTHOIMAGING/OMSIMAGING ACCESSORY by Eastman Kodak Company — Product Code EHD

K040556 is an FDA 510(k) premarket notification submitted by Eastman Kodak Company for the device "TROPHYPAN C WITH ORTHOIMAGING/OMSIMAGING ACCESSORY". The FDA issued a decision of Substantially Equivalent on April 7, 2004. The device falls under product code EHD (Unit, X-Ray, Extraoral With Timer), a Class II device regulated under 21 CFR 872.1800. Eastman Kodak Company has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 7, 2004
Date Received
March 2, 2004
Clearance Type
Special
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Unit, X-Ray, Extraoral With Timer
Device Class
Class II
Regulation Number
872.1800
Review Panel
RA
Submission Type