FDA 510(k)

RSA-CMS

K-Number: K042383 · 2004-10-20

ApplicantMedis Medical Imaging Systems BV

Decision Date2004-10-20

Product CodeLLZ

Advisory CommitteeRA

DecisionSubstantially Equivalent

Device Summary

RSA-CMS is the device name listed in this FDA 510(k) record. The listed applicant is Medis Medical Imaging Systems BV. It received FDA 510(k) clearance on 2004-10-20 under 510(k) number K042383. The device is classified under product code LLZ. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the RSA-CMS?

RSA-CMS is a medical device that received FDA 510(k) clearance on 2004-10-20. The listed applicant is Medis Medical Imaging Systems BV. The 510(k) number is K042383.

When did RSA-CMS receive FDA 510(k) clearance?

RSA-CMS received FDA 510(k) clearance on 2004-10-20, under 510(k) number K042383.

Who is the listed applicant for RSA-CMS?

The FDA 510(k) record lists Medis Medical Imaging Systems BV as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for RSA-CMS?

The FDA product code for RSA-CMS is LLZ.

Other records listing Medis Medical Imaging Systems BV as applicant

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Official Source

View on FDA Database →

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