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FDA 510(k)

MEDICAL COMPRESSOR, MODELS DK50 D AND DM

K-Number: K060781 · 2006-10-03

ApplicantEkom S.R.O.
Decision Date2006-10-03
Product CodeBTI
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

MEDICAL COMPRESSOR, MODELS DK50 D AND DM 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 2006-10-03 under 510(k) number K060781. 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 MEDICAL COMPRESSOR, MODELS DK50 D AND DM?

MEDICAL COMPRESSOR, MODELS DK50 D AND DM is a medical device that received FDA 510(k) clearance on 2006-10-03. The listed applicant is Ekom S.R.O.. The 510(k) number is K060781.

When did MEDICAL COMPRESSOR, MODELS DK50 D AND DM receive FDA 510(k) clearance?

MEDICAL COMPRESSOR, MODELS DK50 D AND DM received FDA 510(k) clearance on 2006-10-03, under 510(k) number K060781.

Who is the listed applicant for MEDICAL COMPRESSOR, MODELS DK50 D AND DM?

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 MEDICAL COMPRESSOR, MODELS DK50 D AND DM?

The FDA product code for MEDICAL COMPRESSOR, MODELS DK50 D AND DM is BTI.

Related Clinical Trials

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.

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.

Related Devices (Code: BTI)

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.

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.

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