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FDA 510(k)

3DTOF MRA

K-Number: K923870 · 1993-01-12

ApplicantResonex, Inc.
Decision Date1993-01-12
Product CodeLNH
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

3DTOF MRA is the device name listed in this FDA 510(k) record. The listed applicant is Resonex, Inc.. It received FDA 510(k) clearance on 1993-01-12 under 510(k) number K923870. 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 3DTOF MRA?

3DTOF MRA is a medical device that received FDA 510(k) clearance on 1993-01-12. The listed applicant is Resonex, Inc.. The 510(k) number is K923870.

When did 3DTOF MRA receive FDA 510(k) clearance?

3DTOF MRA received FDA 510(k) clearance on 1993-01-12, under 510(k) number K923870.

Who is the listed applicant for 3DTOF MRA?

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

What is the FDA product code for 3DTOF MRA?

The FDA product code for 3DTOF MRA is LNH.

Other records listing Resonex, Inc. 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.

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