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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Compressor, Air, Portable
510(k) Number K060781
Device Name MEDICAL COMPRESSOR, MODELS DK50 D AND DM
Applicant
EKOM S.R.O.
32884 DANAPOPLAR
DANA POINT,  CA  92629
Applicant Contact ESTHER SALTZ
Correspondent
EKOM S.R.O.
32884 DANAPOPLAR
DANA POINT,  CA  92629
Correspondent Contact ESTHER SALTZ
Regulation Number868.6250
Classification Product Code
BTI  
Date Received03/22/2006
Decision Date 10/03/2006
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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