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FDA 510(k)

ORTHOVU-1000

K-Number: K981898 · 1998-08-03

ApplicantMagnevu
Decision Date1998-08-03
Product CodeLNH
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

ORTHOVU-1000 is the device name listed in this FDA 510(k) record. The listed applicant is Magnevu. It received FDA 510(k) clearance on 1998-08-03 under 510(k) number K981898. 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 ORTHOVU-1000?

ORTHOVU-1000 is a medical device that received FDA 510(k) clearance on 1998-08-03. The listed applicant is Magnevu. The 510(k) number is K981898.

When did ORTHOVU-1000 receive FDA 510(k) clearance?

ORTHOVU-1000 received FDA 510(k) clearance on 1998-08-03, under 510(k) number K981898.

Who is the listed applicant for ORTHOVU-1000?

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

What is the FDA product code for ORTHOVU-1000?

The FDA product code for ORTHOVU-1000 is LNH.

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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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