FDA 510(k) Application Details - K123681

Device Classification Name Coil, Magnetic Resonance, Specialty

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510(K) Number K123681
Device Name Coil, Magnetic Resonance, Specialty
Applicant WIPRO GE HEALTHCARE PRIVATE, LTD.
122 (PART 1) JOHN F WELCH TRDNG CENTRE, EPIP, WHITEFIELD RD
BANGALORE 560066 IN
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Contact SHASHIDHAR C S
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Regulation Number 892.1000

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Classification Product Code MOS
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Date Received 11/30/2012
Decision Date 02/22/2013
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



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