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FDA 510(k) Application Details - K231459
Device Classification Name
System, Nuclear Magnetic Resonance Imaging
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510(K) Number
K231459
Device Name
System, Nuclear Magnetic Resonance Imaging
Applicant
Resonance Health Analysis Services Pty Ltd
141 Burswood Road
Burswood 6100 AU
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Contact
Mitchell Wells
Other 510(k) Applications for this Contact
Regulation Number
892.1000
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Classification Product Code
LNH
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More FDA Info for this Product Code
Date Received
05/19/2023
Decision Date
06/20/2023
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
RA - Radiology
Review Advisory Committee
RA - Radiology
Statement / Summary / Purged Status
Summary
Type
Special
Reviewed By Third Party
N
Expedited Review
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