FDA 510(k)

DK50 DS

K-Number: K091871 · 2009-10-23

Decision Date2009-10-23

Product CodeBTI

Advisory CommitteeAN

DecisionSubstantially Equivalent

Device Summary

DK50 DS is the device name listed in this FDA 510(k) record. The listed applicant is Ekom S.R.O.. It received FDA 510(k) clearance on 2009-10-23 under 510(k) number K091871. The device is classified under product code BTI. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the DK50 DS?

DK50 DS is a medical device that received FDA 510(k) clearance on 2009-10-23. The listed applicant is Ekom S.R.O.. The 510(k) number is K091871.

When did DK50 DS receive FDA 510(k) clearance?

DK50 DS received FDA 510(k) clearance on 2009-10-23, under 510(k) number K091871.

Who is the listed applicant for DK50 DS?

The FDA 510(k) record lists Ekom S.R.O. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for DK50 DS?

The FDA product code for DK50 DS is BTI.

Other records listing Ekom S.R.O. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K060781MEDICAL COMPRESSOR, MODELS DK50 D AND DM

Related Devices (Code: BTI)

K131881OMBRA TABLE TOP COMPRESSORTrudell Medical Intl.K113338MEDICAL AIR COMPRESSOROricare, Inc.K072634EMG TRITON -COMP,MODEL NCA01-XXX SERIESEmg Technology Co., Ltd.K060781MEDICAL COMPRESSOR, MODELS DK50 D AND DMEkom S.R.O.K051691MINIMATE COMPRESSORPrecision Medical, Inc.K041781VENTILAIR II MEDICAL AIR COMPRESSORHamilton Medical AG

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.