FDA 510(k)

MRJ 3300

K-Number: K122034 · 2012-12-06

Decision Date2012-12-06

Product CodeLNH

Advisory CommitteeRA

DecisionSubstantially Equivalent

Device Summary

MRJ 3300 is the device name listed in this FDA 510(k) record. The listed applicant is Paramed S.R.L.. It received FDA 510(k) clearance on 2012-12-06 under 510(k) number K122034. The device is classified under product code LNH. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MRJ 3300?

MRJ 3300 is a medical device that received FDA 510(k) clearance on 2012-12-06. The listed applicant is Paramed S.R.L.. The 510(k) number is K122034.

When did MRJ 3300 receive FDA 510(k) clearance?

MRJ 3300 received FDA 510(k) clearance on 2012-12-06, under 510(k) number K122034.

Who is the listed applicant for MRJ 3300?

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

What is the FDA product code for MRJ 3300?

The FDA product code for MRJ 3300 is LNH.

Other records listing Paramed S.R.L. 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.

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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.