510(k) K060781

MEDICAL COMPRESSOR, MODELS DK50 D AND DM by Ekom S.R.O. — Product Code BTI

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 3, 2006
Date Received
March 22, 2006
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Compressor, Air, Portable
Device Class
Class II
Regulation Number
868.6250
Review Panel
AN
Submission Type