Cleared Traditional

MEDICAL COMPRESSOR, MODELS DK50 D AND DM

K060781 · Ekom S.R.O. · Anesthesiology

Oct 2006

Decision

195d

Days

Class 2

Risk

About This 510(k) Submission

K060781 is an FDA 510(k) clearance for the MEDICAL COMPRESSOR, MODELS DK50 D AND DM, a Compressor, Air, Portable (Class II — Special Controls, product code BTI), submitted by Ekom S.R.O. (Dana Point, US). The FDA issued a Cleared decision on October 3, 2006, 195 days after receiving the submission on March 22, 2006. This device falls under the Anesthesiology review panel. Regulated under 21 CFR 868.6250.

Submission Details

510(k) Number	K060781 FDA.gov
FDA Decision	Cleared SESE
Date Received	March 22, 2006
Decision Date	October 03, 2006
Days to Decision	195 days
Submission Type	Traditional
Review Panel	Anesthesiology (AN)
Summary	Summary PDF