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FDA 510(k)

MRJ EXTENDED

K-Number: K080098 · 2008-03-10

ApplicantParamed S.R.L.
Decision Date2008-03-10
Product CodeLNH
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

MRJ EXTENDED 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 2008-03-10 under 510(k) number K080098. 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 EXTENDED?

MRJ EXTENDED is a medical device that received FDA 510(k) clearance on 2008-03-10. The listed applicant is Paramed S.R.L.. The 510(k) number is K080098.

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

MRJ EXTENDED received FDA 510(k) clearance on 2008-03-10, under 510(k) number K080098.

Who is the listed applicant for MRJ EXTENDED?

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 EXTENDED?

The FDA product code for MRJ EXTENDED is LNH.

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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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Related Devices (Code: LNH)

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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.

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