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FDA 510(k)

MX CYCLER

K-Number: K905071 · 1991-05-28

ApplicantDakmed, Inc.
Decision Date1991-05-28
Product CodeEKX
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

MX CYCLER is the device name listed in this FDA 510(k) record. The listed applicant is Dakmed, Inc.. It received FDA 510(k) clearance on 1991-05-28 under 510(k) number K905071. The device is classified under product code EKX. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MX CYCLER?

MX CYCLER is a medical device that received FDA 510(k) clearance on 1991-05-28. The listed applicant is Dakmed, Inc.. The 510(k) number is K905071.

When did MX CYCLER receive FDA 510(k) clearance?

MX CYCLER received FDA 510(k) clearance on 1991-05-28, under 510(k) number K905071.

Who is the listed applicant for MX CYCLER?

The FDA 510(k) record lists Dakmed, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for MX CYCLER?

The FDA product code for MX CYCLER is EKX.

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Related Devices (Code: EKX)

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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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