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FDA 510(k)

RESTITU

K-Number: K041937 · 2004-11-16

Decision Date2004-11-16
Product CodeIYE
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

RESTITU is the device name listed in this FDA 510(k) record. The listed applicant is Resonant Medical, Inc.. It received FDA 510(k) clearance on 2004-11-16 under 510(k) number K041937. The device is classified under product code IYE. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the RESTITU?

RESTITU is a medical device that received FDA 510(k) clearance on 2004-11-16. The listed applicant is Resonant Medical, Inc.. The 510(k) number is K041937.

When did RESTITU receive FDA 510(k) clearance?

RESTITU received FDA 510(k) clearance on 2004-11-16, under 510(k) number K041937.

Who is the listed applicant for RESTITU?

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

What is the FDA product code for RESTITU?

The FDA product code for RESTITU is IYE.

Related Clinical Trials

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.

Related Devices (Code: IYE)

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.

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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