FDA 510(k) Application Details - K122111

Device Classification Name Percussor, Powered-Electric

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510(K) Number K122111
Device Name Percussor, Powered-Electric
Applicant RESPIRONICS, INC.
1740 GOLDEN MILE HIGHWAY
MONROEVILLE, PA 15146 US
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Contact COLLEEN WITT
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Regulation Number 868.5665

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Classification Product Code BYI
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Date Received 07/17/2012
Decision Date 12/31/2012
Decision SESE - SUBST EQUIV
Classification Advisory Committee AN - Anesthesiology
Review Advisory Committee AN - Anesthesiology
Statement / Summary / Purged Status Summary
Type Abbreviated
Reviewed By Third Party N
Expedited Review



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