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FDA 510(k)

3.0T PEDIATRIC HEAD AND SPINE ARRAY, MODEL 808GE3000

K-Number: K061170 · 2006-05-25

ApplicantResonance Innovations, LLC
Decision Date2006-05-25
Product CodeMOS
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

3.0T PEDIATRIC HEAD AND SPINE ARRAY, MODEL 808GE3000 is the device name listed in this FDA 510(k) record. The listed applicant is Resonance Innovations, LLC. It received FDA 510(k) clearance on 2006-05-25 under 510(k) number K061170. The device is classified under product code MOS. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the 3.0T PEDIATRIC HEAD AND SPINE ARRAY, MODEL 808GE3000?

3.0T PEDIATRIC HEAD AND SPINE ARRAY, MODEL 808GE3000 is a medical device that received FDA 510(k) clearance on 2006-05-25. The listed applicant is Resonance Innovations, LLC. The 510(k) number is K061170.

When did 3.0T PEDIATRIC HEAD AND SPINE ARRAY, MODEL 808GE3000 receive FDA 510(k) clearance?

3.0T PEDIATRIC HEAD AND SPINE ARRAY, MODEL 808GE3000 received FDA 510(k) clearance on 2006-05-25, under 510(k) number K061170.

Who is the listed applicant for 3.0T PEDIATRIC HEAD AND SPINE ARRAY, MODEL 808GE3000?

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

What is the FDA product code for 3.0T PEDIATRIC HEAD AND SPINE ARRAY, MODEL 808GE3000?

The FDA product code for 3.0T PEDIATRIC HEAD AND SPINE ARRAY, MODEL 808GE3000 is MOS.

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Other records listing Resonance Innovations, LLC 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.

K1304573T DISTAL COIL, 3T ELBOW COIL, 3T LONG BONE COILK0606891.5T PEDIATRIC HEAD AND SPINE ARRAY MODEL

Related Devices (Code: MOS)

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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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