FDA 510(k) Application Details - K241331

Device Classification Name System, Nuclear Magnetic Resonance Imaging

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510(K) Number K241331
Device Name System, Nuclear Magnetic Resonance Imaging
Applicant Springbok, Inc.
100 W. South Street, Suite 1E
Charlottesville, VA 22902 US
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Contact Scott Magargee
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Regulation Number 892.1000

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Classification Product Code LNH
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Date Received 05/10/2024
Decision Date 10/01/2024
Decision SESE - SUBST EQUIV
Classification Advisory Committee RA - Radiology
Review Advisory Committee RA - Radiology
Statement / Summary / Purged Status Summary
Type Traditional
Reviewed By Third Party N
Expedited Review

FDA Source Information for K241331


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