FDA 510(k) Application Details - K120520

Device Classification Name Couch, Radiation Therapy, Powered

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510(K) Number K120520
Device Name Couch, Radiation Therapy, Powered
Applicant BRAINLAB AG
KAPELLENSTRASSE 12
FELDKIRCHEN 85622 DE
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Contact ALEXANDER SCHWIERSCH
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Regulation Number 892.5770

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Classification Product Code JAI
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Date Received 02/21/2012
Decision Date 06/29/2012
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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